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U.S. Department of Health and Human Services

MedSun: Newsletter #43, December 2009

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Newsletter #43, December 2009

Articles

Stryker Operating Room System II Surgical Navigation System - Recall

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FDA MedWatch Safety Alert

Stryker and FDA notified healthcare professionals of a recall of 23 Operating Room System II Surgical Navigation Systems because there is a potential for the navigation PC SPC-1 component to stop working which could result in the screen freezing, the system updating at a slow rate, or not responding at all.

Additional Information:

FDA MedWatch Safety Alert. Stryker Operating Room System II Surgical Navigation System - Recall. November 27, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm192105.htm

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Cardiac Science Corp. Powerheart and CardioVive Automated External Defibrillators: Initial Communication

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FDA MedWatch Safety Alert

Cardiac Science Corporation has received multiple complaints related to defective components in these AEDs that indicate the affected devices may not deliver electric shocks and that the devices' self-test may not detect the defect in advance of their use. 300,000 Cardiac Science AEDs worldwide are potentially affected by this problem. The G3 Series devices were manufactured between August 2003 and August 2009. Because the AED display screen and/or audible indicators may not accurately indicate whether the device is functioning properly or will function properly at time of use, FDA encourages users of the affected AEDs to follow the additional precautions provided in this communication. FDA is gathering more data about this situation to better understand its potential public health impact and will make available any new information that might affect the use of these AED devices.

Additional Information:

FDA MedWatch Safety Alert. Cardiac Science Corp. Powerheart and CardioVive Automated External Defibrillators: Initial Communication. November 19, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm191471.htm

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Preventing Cross-Contamination in Endoscope Processing - Safety Communication from FDA, CDC, and the VA

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FDA Medical Device Safety website

This communication cautions healthcare facilities, including hospitals, ambulatory care facilities and private practices, about the risks to patients if flexible endoscopes and their accessories are not processed properly, and recommends steps to reduce these risks. It is being issued jointly by the U.S. Food and Drug Administration, the Centers for Disease Control and Prevention, and the Department of Veterans Affairs, and has been reviewed by The Joint Commission. The communication also reminds manufacturers of endoscopes and endoscope processing equipment of their responsibilities in helping assure proper endoscope processing in healthcare facilities.

Additional Information:

FDA Medical Device Safety website. Preventing Cross-Contamination in Endoscope Processing - Safety Communication from FDA, CDC, and the VA. November 19, 2009.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm190273.htm

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Cardiovascular Systems ViperSheath Sheath Introducer - Recall

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FDA MedWatch Safety Alert

Cardiovascular Systems, Inc. and FDA notified healthcare professionals of a nationwide recall of all lots of the ViperSheath Sheath Introducer on behalf of Thomas Medical due to reports about stretching or fracture of the sheath during use. In the event of a device fracture, separated segments of the device may require unplanned open surgery to remove the retained segments or control bleeding. Since this device is coil reinforced, any separation of the cannula (a flexible tube inserted into the body) has the potential to expose portions of the coil, creating the potential for vessel dissection or perforation.

Additional Information:

FDA MedWatch Safety Alert. Cardiovascular Systems ViperSheath Sheath Introducer – Recall. November 16, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm190967.htm

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Negative Pressure Wound Therapy (NPWT) systems - Preliminary Public Health Notification

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FDA MedWatch Safety Alert

FDA notified healthcare professionals of a Preliminary Public Health Notification describing deaths and serious complications associated with the use of Negative Pressure Wound Therapy (NPWT) systems. FDA has received reports of six deaths and 77 injuries associated with NPWT systems over the past two years. NPWT systems are generally indicated for the management of wounds, burns, ulcers, flaps and grafts. Healthcare professionals were advised to select patients for NPWT carefully, after reviewing the most recent device labeling and instructions. Patients should be monitored frequently in an appropriate care setting by a trained practitioner, and practitioners should be vigilant for potentially life-threatening complications, such as bleeding, and be prepared to take prompt action if they occur.

Additional Information:

FDA MedWatch Safety Alert. Negative Pressure Wound Therapy (NPWT) systems - Preliminary Public Health Notification. November 16, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm190704.htm

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Synthes USA, Ti Synex II Vertebral Body Replacement - Class I Recall

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FDA MedWatch Safety Alert

FDA notified healthcare professionals of a Class I Recall of all lots of the Synthes USA, Ti Synex II Vertebral Body Replacement, a device used in the T1-L5 portion of the spine to replace a collapsed, damaged, or unstable vertebral body. Reports of moderate to severe loss of vertebral body replacement height (caused by failure of the central body component) in situ at six to fifteen months post implantation were received. Potential adverse health issues that could be associated with this issue include neural injury, increased pain, spinal kyphosis if unrecognized, failure of supplementary fixation, and/or need for reoperation/revision surgery. Surgeons and hospitals in possession of the subject devices must stop implanting them immediately.

Additional Information:

FDA MedWatch Safety Alert. Synthes USA, Ti Synex II Vertebral Body Replacement - Class I Recall. November 12, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm190330.htm

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External Biphasic Defibrillators Energy Levels: Initial Communication

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FDA MedWatch Safety Alert

FDA notified healthcare professionals that it is investigating energy levels in external biphasic defibrillators with shocks = 200 J. FDA received reports of 14 events since 2006 in which a 200 J biphasic defibrillator was ineffective in providing defibrillation/cardioversion therapy to a patient, whereas a subsequent shock from a different 360 J biphasic defibrillator resulted in immediate defibrillation/cardioversion. Analysis of the 14 cases does not suggest the need for any change to current clinical practice, and as FDA continues its evaluation of this situation, providers are encouraged to follow the American Heart Association’s guidelines/algorithms for treatment of cardiac arrhythmias, and to follow manufacturers’ instructions for using defibrillators. FDA is seeking additional information in order to interpret the significance of these events, and to determine whether FDA activities are advised.

Additional Information:

FDA MedWatch Safety Alert. External Biphasic Defibrillators Energy Levels: Initial Communication. November 10, 2009.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm189259.htm

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Edwards Lifesciences CardioVations EndoClamp Aortic Catheter - Class 1 Recall

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FDA MedWatch Safety Alert

FDA and Edwards Lifesciences notified healthcare professionals about the Class 1 recall of CardioVations EndoClamp Aortic Catheter, Model Numbers EC1001 and EC65, a device that blocks off the aorta, monitors aortic pressure, and delivers solution to stop the heart during cardiopulmonary bypass procedures. The recall was initiated because the balloon catheters may spontaneously rupture during surgery. This product was manufactured from August, 2008 through August, 2009 and distributed from November, 2008 through September, 2009.

Additional Information:

FDA MedWatch Safety Alert. Edwards Lifesciences CardioVations EndoClamp Aortic Catheter - Class 1 Recall. November 9, 2009.
http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm189615.htm

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Centurion Medical Products - Premie Pack and Meconium Pack - Recall

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FDA MedWatch Safety Alert

Centurion Medical Products and FDA notified healthcare professionals about a Class I recall of Premie Pack, Kit Code LM 110 and Full Term Meconium Pack, Kit Code LM115. The pediatric tracheal tubes used in these kits were manufactured with an internal diameter smaller than indicated on the label, which could result in an inability to remove secretions and cause partial or complete blockage of the airway and the inability to ventilate the patient.

Additional Information:

FDA MedWatch Safety Alert. Centurion Medical Products - Premie Pack and Meconium Pack – Recall. November 4, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm188981.htm

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Reminder from FDA: Cybersecurity for Networked Medical Devices is a Shared Responsibility

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FDA Medical Device Safety website

FDA wants to remind you that cybersecurity for medical devices and their associated communication networks is a shared responsibility between medical device manufacturers and medical device user facilities. The proper maintenance of cybersecurity for medical devices and hospital networks is vitally important to public health because it ensures the integrity of the computer networks that support medical devices. FDA is aware of misinterpretation of the regulations for the cybersecurity of medical devices that are connected to computer networks. FDA’s interpretation of the regulations can be found in the 2005 guidance for industry and its accompanying information for healthcare organizations.

Additional Information:

FDA Medical Device Safety website. Reminder from FDA: Cybersecurity for Networked Medical Devices is a Shared Responsibility. November 4, 2009.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm189111.htm

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Cordis CROSSOVER Sheath Introducer - Recall

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FDA MedWatch Safety Alert

Cordis and FDA notified healthcare professionals of a nationwide recall of all lots of the CROSSOVER Sheath Introducer. The recall was due to stretching or fracture of the sheath during use. In the event of a device fracture, separated segments of the device can embolize downstream in the bloodstream and impede blood flow distal to the point where it lodges, resulting in ischemia or infarct to the distal extremity. Since this device is coil reinforced, any separation of the cannula has the potential to expose portions of the coil creating the potential for vessel dissection or perforation. Unplanned open surgery may be required to remove the retained segments or control bleeding.

Additional Information:

FDA MedWatch Safety Alert. Cordis CROSSOVER Sheath Introducer – Recall. October 30, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm188555.htm

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Accusure Insulin Syringes (Qualitest Pharmaceuticals) - Recall

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FDA MedWatch Safety Alert

Qualitest Pharmaceuticals and FDA notified healthcare
professionals of a nationwide recall of Accusure Insulin Syringes. All syringes, regardless of lot number, are subject to this recall. The syringes in these lots may have needles which detach from the syringe. If the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into to the syringe, or remain in the skin after injection.

Additional Information:

FDA MedWatch Safety Alert. Accusure Insulin Syringes (Qualitest Pharmaceuticals) – Recall. October 27, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm188151.htm

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LabNet

Pointe Scientific Liquid Glucose Hexokinase Reagent - Recall

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FDA MedWatch Safety Alert

Pointe Scientific and FDA notified healthcare professionals of a nationwide recall of all size kits of Liquid Glucose Hexokinase Reagent catalog number G7517. The reagents have been found to fail linearity at >200mg/dL that results in inaccurate glucose values above this range. Distributors and testing laboratories who have received the Liquid Glucose Hexokinase Reagent (G7517) which is being recalled should destroy remaining inventory. Testing laboratories should consider all test results obtained with the lot numbers listed above to be questionable. The laboratory should inform the patient’s attending physician, and determine, with their input, whether confirmation of the previous test results will be required.

Additional Information:

FDA MedWatch Safety Alert. Pointe Scientific Liquid Glucose Hexokinase Reagent – Recall. November 6, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm188562.htm

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The Pursuit of Traceability: Lab Groups Push for Greater Harmonization

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AACC Clinical Laboratory News
By Bill Malone

Laboratorians are familiar with the challenges that can arise when different methods, instruments, and labs produce different results for the same analyte. However, physicians and patients often don't fully grasp the significance of these variations, leading to a host of problems. It’s this inconsistency that the lab community now hopes to resolve by engaging the concepts of a science known as metrology.

Additional Information:

The Pursuit of Traceability: Lab Groups Push for Greater Harmonization. AACC Clinical Laboratory News. Malone, Bill. October 2009.
http://www.aacc.org/publications/cln/2009/october/Pages/CoverStory1Oct09.aspx

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HomeNet

Advice for Patients: Serious Complications with Negative Pressure Wound Therapy Devices

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FDA MedWatch Safety Alert - Advice For Patients

Please see the Preliminary Public Health Notification alerting healthcare providers and patients of issues with Negative Pressure Wound Therapy systems (NPWT). The Advice for Patients notice provides recommendations for patients using NPWT.

Additional Information:

Advice for Patients: Serious Complications with Negative Pressure Wound Therapy Devices. November 16, 2009.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PatientAlerts/ucm190476.htm

FDA MedWatch Safety Alert. Negative Pressure Wound Therapy (NPWT) systems - Preliminary Public Health Notification. November 16, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm190704.htm

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A New Online Guide to Hearing Aids

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FDA Consumer Update website

The FDA has launched a new website that will benefit current and potential users of hearing aids. The site includes sections on: general information on hearing aids, types of hearing loss, types and styles of hearing aids, how to get a hearing aid, benefits and safety of hearing aids, hearing aids and cell phones and other products and procedures that people can use to improve hearing. The website also has a checklist of steps to consider before purchasing hearing aids.

Additional Information:

FDA Consumer Update website. A New Online Guide to Hearing Aids. October 20, 2009.
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm185723.htm

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SightNet

LASIK: Quality of Life Project, Warning Letters to Facilities

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FDA Consumer Update website

On Oct. 15, 2009, the FDA made two announcements related to LASIK: The launch of a collaborative study to examine the potential impact on individuals' quality of life from LASIK surgery, and the issuance of warning letters to 17 LASIK ambulatory surgical centers-those that perform surgery and release patients the same day—after inspections revealed inadequate systems for reporting unexpected side effects (adverse events).

Additional Information:

FDA Consumer Update website. LASIK: Quality of Life Project, Warning Letters to Facilities. October 20, 2009.
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm187351.htm

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Keep An Eye Out For Contact Lens Problems

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FDA Medical Device Safety website
By Eileen Woo

The FDA has received several reports of corneal ulcers, keratitis, and other eye infections associated with using daily disposable contact lenses for longer than the period recommended. Ophthalmologists and other eye care professionals believe the reported problems are caused by contact lens wearers’ poor hygiene and failure to follow directions when using and caring for these types of lenses. Reports of consumers wearing daily disposable contact lenses for 6 or 7 days instead of 1 day are of particular concern. Eye problems, including corneal ulcers, can develop rapidly and lead to loss of vision. This article gives precautions consumers can take to help prevent these problems.

Additional Information:

FDA Medical Device Safety website. Keep An Eye Out For Contact Lens Problems. Woo, Eileen. Reprinted from Nursing2009. Volume 39, Issue 11.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm189507.htm

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Announcement: Vision Health Initiative Website

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CDC MMWR

CDC has created a new Vision Health Initiative website with information regarding vision and eye health, projects with diverse stakeholders, journal publications and reports, and vision health--related resources for professionals and consumers. The website includes an interactive map displaying state-specific vision and eye health statistics. With this tool, states that use the Behavioral Risk Factor Surveillance System visual impairment and access to eye care module can produce reports and presentations with data specific to their states. The website can be accessed at http://www.cdc.gov/visionhealth.

Additional Information:

CDC MMWR. Announcement: Vision Health Initiative Website. November 6, 2009.
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5843a4.htm?s_cid=mm5843a4_e

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Highlighted MedSun Reports

Highlighted Reports

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This section contains a sample of reports from all the MedSun reports received during a particular period. The reports were submitted by MedSun Representatives. In some instances the reports have been summarized and/or edited for clarity. The entries that follow represent a cross section of device-related events submitted by MedSun reporters during the period September 1 through September 30. All other reports can be searched under the ‘MedSun reports’ menu pane. Note: the two month delay is due to quality control and follow-up.


ANESTHESIOLOGY

Device:

Type: Flexible Patient Circuit With Filter
Manufacturer: Viasys Healthcare, Respiratory Care
Brand: Flexible Patient Circuit With Filter For 3100b Hfov And Fisher &Paykel Mr850 Humidifier.
Model#: P/N 16390-102
Lot #: 050409
Cat #: (not provided)
Other #: P/N L2712-102A also MO11163901

Problem:
Two Viasys HFOV (High Frequency Oscillatory Ventilator) Circuits were defective at the connection near the control valve. It keeps slipping off, not staying sealed, like it should have been glued but was not. Neither circuit was connected to a patient, so there was not any harm. One was noticed after it had been in storage and the other one was found yesterday as it was getting checked prior to patient use as it would not pass calibration.


Device:

Type: High Frequency Oscillatory Ventilator
Manufacturer: Care Fusion Cardinal Health
Brand: Sensormedics
Model#: 3100A
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
During setup prior to connection to patient, respiratory technician was unable to calibrate mean circuit pressure on high frequency oscillatory ventilator (HFOV). Respiratory therapist noted that the mean pressure adjust knob had turned past its mechanical stop and the RT was unable to calibrate ventilator. Ventilator exchanged and sent to Biomedical for repair.

Biomedical noted that the adjustment knob pointer was also used as the adjustment stop for the knob in the 5 O'clock maximum setting point. The stop post is a 2-56 threaded screw extending from the control panel. What we noted was the knobs pointer was forced past the stop post and the user could not calibrate the ventilator after that point. The knob can easily slip past the stop post with little or no user effort. Biomedical temporarily thickened the stop post by adding a 1/8" length of shrink tube over the screw. This prevented the knob from slipping past the stop post. We concluded that a minor design change may be needed to prevent the knob from going past the max adjust point.
Comment from FDA: Good example of Human Factors issue.


CARDIOVASCULAR

Device:

Type: Catheter, Ep, Mapping
Manufacturer: St. Jude Medical Cardiac Rhythm
Brand: Inquiry Optima
Model#: (not provided)
Lot #: K12445
Cat #: 1120-7-1(4.5)-SM-OPT25
Other #: (not provided)

Problem:
During the procedure, the catheter would no longer deflect or change the position of its curvature. The catheter was replaced with a new one. There was no harm to the patient.


Device:

Type: Defibrillator, External
Manufacturer: Zoll Medical Corporation
Brand: RSeries Defibrillator
Model#: R series
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
There was NOT a specific event involving a patient. We have discovered a design issue with the Zoll Medical R series defibrillators. Our facility has purchased 75 of these defibrillators which were placed on the nursing units one month ago. Since that time we have noted several issues:
(1) Zoll has supplied non hospital grade pigtail extensions,
(2) There is no locking device for the pigtail extension to the defibrillator, thus the connection is regularly being inadvertently disconnected and
(3) The pigtail extension does not properly connect with the hospital grade gray power cord. All of the components in this report are original equipment issued from the manufacturer.

First, in Zoll’s assembly recommendations, we followed the instructions that tell us to place the pigtail extension between the defibrillator and the hospital grade ac power cord (clearly marked hospital grade). This pigtail extension is 12 inches in length. But nowhere on the pigtail extension itself does it indicate that it is hospital grade. All hospital equipment used on patients must be powered by a hospital grade power cord per our facility policy. Zoll has informed us that this pigtail is not hospital grade. We are not sure of the purpose of this pigtail extension.

The second issue, there have been 9 trouble calls in our hospital where the pigtail extension is coming loose from the inlet receptacle on the defibrillator and is not charging the defibrillator battery. These problems were noted by nurses during daily defibrillator inspections. As an acting strain relief, a tie wrap was provided by the manufacturer along with illustrations on assembling the tie wrap to the unit to hold the pigtail extension. These were assembled prior to placing the defibrillators on the nursing units. However, this tie wrap does not sufficiently hold the pigtail extension in place to the (IEC receptacle) defibrillator causing it to come loose and not charge.

Third, we have also noticed the pigtail extension does not connect properly with the gray power cord. There is a 1/16 inch gap between the two connections and it appears the gray cord has a longer molded body which exceeds the female end of the pigtail cable.

Manufacturer response (as per reporter) for defibrillator, R series defibrillator

Our Director of Bio Medical has contacted the manufacturer to discuss our concerns. We have been informed by Zoll that they have received similar complaints of these issues from other facilities.

See device image
RSeries Defibrillator



Device:

Type: Defibrillator, Icd
Manufacturer: St. Jude Medical Cardiac Rhythm
Brand: Atlas +Dr
Model#: V-243
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
The patient is an adolescent with a history of catecholamine induced ventricular fibrillation and cardiac arrest. He has normal left ventricular systolic function. He received his initial ICD system after suffering an out of hospital cardiac arrest. Approximately 1 month ago, he was at the dinner table, got up and was carrying his plate and received a shock from his defibrillator. On interrogation of his device, shocks were inappropriate and secondary to likely fractured right ventricular (RV) lead conductor fracture. Per his request, his defibrillator was turned off. He was admitted for ICD lead removal with submuscular implantation of his ICD. After the RV lead was completely extracted, it was noted that a 2mm portion of the lead had fractured.
Since the ICD was almost 3.5 years old, it was not uncommon to change it out. The patient is doing well.

Manufacturer response (as per reporter) for AICD RV lead and AICD generator:
Awaiting response.


Device:

Type: Hyperthermia Unit, Forced Air
Manufacturer: Arizant Healthcare Inc
Brand: Bair Hugger
Model#: 750
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
Post operative patient requested warming blanket. Staff covered patient with a warmer blanket attached to an Arizant 750 warmer. Shortly after staff noticed a "hot" smell near the patient. The smell was quickly narrowed down to the 750 warmer and it was removed from use and Biomed was called. On inspection the Biomed found the molded power cord plug charred. The power cord was replaced and the unit tested OK.

This is the second occurrence of this problem on units purchased last year. The other unit had cord issues ~3 months ago.
Comment from FDA:
For more information about recent power cord issues, please see:
Medical Device Power Cords Safety Investigation: Initial Communication online available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm187117.htm and
Safety Investigation of Certain Medical Device Power Cords: Initial Communication online available at: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm187078.htm



Device:

Type: Interface Cable, Catheter Connector
Manufacturer: Biosense Webster
Brand: Hypertronics 25-pin
Model#: (not provided)
Lot #: 14068577
Cat #: C5MHNAVMHS
Other #: (not provided)

Problem:
The interface cable connection was defective. This was an out-of-the box failure. The cable would not display on the monitor that the catheter was connected. This cable is used between the catheter handle and the patient interface unit (PIU). The cable was replaced, and the catheter was displayed on the monitor. There was no harm to the patient.


Device:

Type: Monitor, Physiological
Manufacturer: Philips Medical Systems
Brand: Intellivue
Model#: MP70
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
After removing a BP cuff from a patient, a critical care nurse placed the rolled up cuff and tubing between the module rack and display of a Philips IntelliVue MP70 patient bedside monitor. This monitor was mounted above and adjacent to the patient bed but the mount was swiveled away from the bedside (not directly overhead). The auto-inflate setting was inadvertently left "on" for BP monitoring and it activated shortly after the RN left the patient's room. As it inflated it lifted the bedside monitor off of the two 1" mounting pins that it normally rests on. A spring loaded mechanical latch must normally be pressed in order to disengage the monitor from these pins but for some reason it had not automatically returned to a safe position. The upward pressure caused by the overinflated BP cuff subsequently caused the monitor to lift off of its mount and crash to the floor. The Philips IntelliVue MP70 is a bedside monitoring "system". Because it employs a modular design the modules themselves (i.e. BP module, SpO2 module, Multi-Measurement Server (MMS) and Pressure modules are all separate from the display monitor. They are contained in a separate module rack but as a whole constitute the IntelliVue Monitoring System. In this case the MMS, specifically the BP circuit, played a major role in this event.

See device images
Philips Monitor 1

Philips Monitor 2


Device:

Type: Stent, Cardiac, Bare Metal
Manufacturer: Boston Scientific
Brand: Liberte Bare Metal Stent
Model#: (not provided)
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
Patient had a cardiac catheterization with stent placement. The physician requested a Liberte Bare Metal Stent and was given a Taxus Liberte (drug eluting) stent. The Taxus Liberte was deployed and documented by nursing in the patient's medical record. The patient was given a wallet card bearing this information. The physician documented in the medical record that he inserted a bare metal stent. Several months later in the process of clearing the patient for knee surgery, the patient’s primary care provider wanted/needed to discontinue the antiplatelets and discovered a discrepancy between the stent he thought had been inserted vs. the information provided to him by the doctor who performed catheterization/stent placement. There was no harm to the patient; however, it was thought that the surgery might be delayed due to the need to continue aspirin and Plavix therapy. The physician who placed the stent stated that packaging for both stents are identical, same box, same labeling. He does not see the box, and is only handed the equipment. The device type is "microscopically stamped" on the equipment itself but "who can see that?"

Comment from FDA - UPDATE: Boston Scientific has changed the name of the company's Liberté Bare-Metal coronary stent to VeriFLEX. The company took this action after reports that Liberté Bare-Metal stents were inadvertently implanted instead of TAXUS Liberté Drug-Eluting stents, and vice versa. The TAXUS Liberté Drug-Eluting stents will keep the same name. The company is re-labeling the outer boxes of all Liberté Bare-Metal stents currently in facilities' inventories. However, the pouch label, patient guide and directions for use card for these products are not being re-labeled at this time and will still bear the Liberté name. Boston Scientific is offering to provide hospitals and cath labs with additional information and training.

See device image
Liberte Bare Metal Stent

Taxus Liberte Drug Eluting Stent


For more information visit:
FDA Patient Safety News (video) - Liberté Coronary Stent Now Called VeriFLEX – November 2009 online available:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=92#4 and

Boston Scientific Field Correction Notice. Important Notice about the use of Liberté Bare-Metal coronary stents and TAXUS Liberté Paclitaxel Eluting coronary stents. September 18, 2009 online available:
http://www.bostonscientific.com/templatedata/imports/collateral/Coronary/liberte-field-action-091109.pdf



EAR, NOSE, & THROAT

Device:

Type: Cochlear Implant
Manufacturer: Advanced Bionics LLC
Brand: Advanced Bionics
Model#: (not provided)
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
First cochlear implant was defective. Second cochlear implant was implanted. Per audiology testing, there was a "hardware connection problem while communicating with implant." Audiologists checked connections and did the test a few more times, with the same result. Kept implant in patient, hoping that computer software is malfunctioning, rather than the implant.


GASTROENTEROLOGY & UROLOGY

Device:

Type: Biopsy System, Breast
Manufacturer: Ethicon Endo-Surgery, Inc.
Brand: Mammotome (R)
Model#: MRP08XP
Lot #: E4M2LU, E4KE7G
Cat #: (not provided)
Other #: probe-F4NX66 and target set F4P57M (last case), PI1-46R2HK, PI1-46EOCY

Problem:
Patient had an MRI guided core biopsy as part of our trial of the J&J Mammotome system. MD noted that samples have what appears to be "black" looking material with the actual biopsy tissue. 8 samples taken on this pt - all but one had this visible black material. Vendor rep present stated she had not seen this before. Tried system again with different patient and different lot number and saw the same thing. Trial discontinued. Pathology evaluation described pliable, amorphous without architecture or structure under the microscope.

Manufacturer response (as per reporter) for percutaneous breast biopsy, Mammotome (R)

We are waiting for the results of their quality analysis. Several manufacturer reps were present at the time this was identified - it is my understanding that all expressed that they had not seen this phenomenon before.


Device:

Type: Hemodialysis, Crrt
Manufacturer: Gambro Renal Products, Inc.
Brand: Prismaflex
Model#: Prismaflex
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
Machine was alarming increased negative pressure. Lines flushed without difficulty. Machine continued to alarm therefore attempted to inverse the lines. Upon completion attempted to continue therapy and the screen was frozen. The filter then became clotted.


Device:

Type: Intraperitoneal Hyperthermia System
Manufacturer: ThermaSolutions
Brand: Thermochem
Model#: HT-1000
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
Thermocare machine was being used with a HIPEC (Heated Intraoperative Intraperitoneal Chemotherapy) case. The perfusionist said the screen froze. Temperature regulation via the machine was disabled and manual temperature regulation measures were used to proceed with the case. There was no effect/injury to the patient. Our BioMed department did not assess the device as it was returned to the manufacturer's representative immediately after the case. (This is not our procedure and that has been addressed at our level). BioMed reports that this is the third time in four cases that we have had problems with an HT-1000 from ThermaSolutions. All the occurrences indicate screen issues. However, there are no other similar devices available per BioMed department.


GENERAL & PLASTIC SURGERY

Device 1:

Type: Blade Electrode, Esu, Coated
Manufacturer: COVIDIEN LP
Brand: Edge
Model#: (not provided)
Lot #: (not provided)
Cat #: E1455
Other #: (not provided)

Device 2:

Type: Electrode, Esu, Handswitching Pencil
Manufacturer: COVIDIEN LP
Brand: Valleylab
Model#: (not provided)
Lot #: (not provided)
Cat #: E2515
Other #: (not provided)
Device 3:
Type: Esu
Manufacturer: Covidien Valley Lab
Brand: Force Fxc
Model#: (not provided)
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
The physician was performing a breast reconstruction procedure when the single-use ESU pencil hand piece sparked and physician's finger was burned (a minor burn). An arc from the ESU pencil's cord sparked across a surgical staff member's arm (no injury). The ESU pencil and blade electrode were sent to Biomedical Engineering for inspection. (The ground pad was discarded and so was not available for inspection.) The technician noted a large amount of debris built up on the electrode tip. The power out of the ESU was tested and passed. The pencil's cable assembly was flexed and there was no effect on power delivery noted. A new pencil electrode blade was placed on the ESU and results were the same. The Valley Lab Force FX was placed back into service. The single-use ESU pencil and blade electrode are available by request if the manufacturer would like to further inspect them.

Comment from FDA: Please see ValleyLab’s website for more information about ESUs and coated electrodes online available: http://www.valleylab.com/education/poes/poes_30.html


Device:

Type: Electrosurgical Unit
Manufacturer: COVIDIEN LP
Brand: Force Fx
Model#: (not provided)
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
Patient was undergoing open heart surgery for mitral valve replacement and coronary artery bypass. The electrosurgical unit was under the surgical drapes when a cracking noise was heard. The drape was removed revealing a half-dollar sized full thickness burn. The bovie was immediately taken out of service and sent to Bio Medical Engineering. The surgeon documented in the OR report that there appeared to be a defect in the cautery cord which then conducted through a clamp and burned the patient's thigh. The OR staff thought the burn might have been caused by user error by a Physician Assistant. They commented that the bovie may not have been placed back in the holster under the drapes with the cord lying on top of the thigh.


Device:

Type: Instrument, Mallet
Manufacturer: Biomet, Inc.
Brand: No Bounce Mallet
Model#: (not provided)
Lot #: 124080
Cat #: 740042
Other #: (not provided)

Problem:
A sterile mallet broke open during a surgical procedure. The interior contents of pellets and powder spilled onto the sterile field into the wound. This was immediately isolated. Extra antibiotics were given to the patient. X-rays were taken and read as negative.


Device:

Type: Stapler, Anvil
Manufacturer: Covidien United States Surgical Corporation
Brand: Dst Series Eea Orvil
Model#: EEAORVIL21
Lot #: U8K126
Cat #: EEAORVIL21
Other #: (not provided)

Problem:
The ORVIL anvil would not position to attach to the EEA stapler like it is supposed to; so the Orvil device on the delivery tube had to be removed. A new Orvil device was used to complete the procedure. No apparent harm.


Device:

Type: Stapler, Reload, Surgical
Manufacturer: Covidien United States Surgical Corporation
Brand: Endo Gia
Model#: (not provided)
Lot #: N8D203
Cat #: 030426
Other #: US200902-0175, straight 45mm x 2.0mm

Problem:
Surgeon tried to use stapler but there was a loud pop and a small piece (about 1cm) of the mechanical linkage broke off the staple load and fell into the patient. It was retrieved but the stapling could not be completed.

Manufacturer response (as per reporter) for Stapler, Reload, Surgical, Endo GIA
[The device was a straight load but was reported to the company with the catalog number of an articulating one.] Quality Assurance and Engineering evaluated a partially applied ENDO GIA™ II 45-2.0mm Single Use Loading Unit and were unable to detect any discrepancies related to components or manufacture of the product. However, it was observed that the anvil was severely bowed, and the clamp bar had fractured at the hook above the knife blade. Material testing on the fractured clamp bar noted no abnormalities. Replication of damage such as anvil deformities and fractured clamp bars may occur under the following conditions:
1. Application over tissue that is beyond the recommended thickness range.
2. Firing with an obstacle incorporated in the jaws. In any of these circumstances, it will become increasingly difficult to actuate the firing handle and the instrument return knobs will be difficult to retract. In addition, staples may not form properly and tissue may not be fully transected.
The information booklet which accompanies each product shipment offers the following as a warning and precaution. "1. Preoperative radiotherapy may result in changes to tissue. These changes may. For example, cause the tissue thickness to exceed the indicated range thickness for the staple size. Careful consideration should be given to any pre-surgical treatment the patient may have undergone and in corresponding selection of staple size. 2. Always include the combined thickness of the tissue and any staple reinforcement material in use when choosing the proper staple cartridge."

See device image
Stapler


GENERAL HOSPITAL

Type: Infusion Tubing
Manufacturer: B. Braun Medical, Inc.
Brand: Ultrasite Outlook Safety Infusion System Iv Set
Model #: 470042
Lot #: (not provided)
Other #: US1504HP
Problem:
It has been brought to our attention our staff have been receiving an increase in "System Error 9" alarms from our B. Braun Outlook 100 pumps. Correspondence from B. Braun indicates they have tested various factors that could be contributed to the System Error 9 alarms resulting from the IV pump sets. Typically once the IV tubing is switched out the issue is remedied. B. Braun’s correspondence indicates their (quoted from letter) "testing to date has identified on a small percentage of IV set pump cassettes, the fluid channel was deformed during the manufacturing process. When these sets are placed into the Outlook and/or NXT pump, a system error 9 alarms may occur. The channel deformation has been determined to be a result of the properties of the resin material that was used to mold the rigid cassette. Use of this particular lot of resin has been discontinued." B. Braun has also indicated they will continue to work through this issue.

Clinical Engineering reported they have had 5 pumps returned to them over a two week period which all had "System Error 9" reports. Once the tubing was switched out the pumps ran fine. Unfortunately these incidents had not been reported to our office and our CE department did not retain the tubing in these incidents but have now been encouraged to do so. We have previously reported other "error 9" concerns.
Comment from FDA: MedSun has received similar reports from four different sites.

Device 1:

Type: Bed, Hospital
Manufacturer: Hillrom
Brand: Bed
Model#: P1900 Total Care Bed
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Device 2:

Type: Patient Bed Exit Monitor
Manufacturer: Direct Supply, Inc.
Brand: Economy Alarm
Model#: Attendant
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
A nurse reported that a care alert alarm (portable alarm) was de-activated when it was placed in close proximity to the bed speaker. Biomedical Services was asked to research why the alarm did not sound. Upon inspection, Biomedical Services found that Hill-Rom Bed model; Advance, Advanta, Total Care, and Versa Care bed’s speaker magnet can de-activate the magnetically activated portable alarm. If one of the portable alarms is near the Hill-Rom bed speaker it will not alarm. The bed’s speaker magnet keeps the portable alarm switch from activating. Hand held pillow speakers and beds from another manufacturer side rail speakers do not deactivate the portable alarms. Medical staff should always take care to secure the portable alarms away from any magnetic source. Hill-Rom Tech support was notified, and Biomedical Services were told that they would file a report. No reference number was given.

Manufacturer response (as per reporter) for Bed,

No feedback. He will file a report.


Device:

Type: Bed, Hospital, Electric
Manufacturer: Hill-Rom Company, Inc.
Brand: Total Care Gc
Model#: TOTAL CARE GC
Lot #: NA
Cat #: NA
Other #: NA

Problem:
Patient and two friends in room for stair transfer trial. Bed rail and bed height adjusted for additional right rail support, stair present in front of pt with wheeled walker available anteriorly. Upon repositioning of bilateral upper extremity (UE) support, and during education/discussion of procedure for stair transfer, the patient initiated the stair ascent prior to completion of patient education regarding adherence to bilateral UE force/push/pull restriction. The right bed rail fell while the pt had his right foot on the step, left UE supported by the walker. No fall occurred. Pt remained in place with gait belt support and started to walk away from the step and resisted cues for return to sitting position on bed. Nursing, nurse practitioner and resident aware, clinical exam initially unchanged, 10" following pt volitionally logrolling and sitting up to edge of bed to walk with nursing assist. Pt reported a change in left below knee numbness and was unable to maintain 5/5 left dorsiflexion.

Manufacturer response (as per reporter) for Electric Bed - Hospital, TOTAL CARE GC

Manufacturer is in process of modifying side rails.


Device:

Type: Enclosed Chemotherapy Administration Set/phaseal Injector
Manufacturer: Carmel Pharma
Brand: Phaseal
Model#: N35
Lot #: various
Cat #: (not provided)
Other #: Connector C45

Problem:
The Phaseal closed chemotherapy delivery system is problematic on our pediatric floors in a variety of ways. The injector contains a needle, and in order to prevent the needle from tearing a hole in the clave and causing a leak, we have to use a PhaSeal connector.

We give chemotherapy to our pediatric patients via three methods: push with a syringe, an IM injection or as a continuous infusion with a bag. The first issue is that the PhaSeal device is not compatible with the syringe pump we use (Medfusion), so in order to push a syringe, we have to use an infusion pump. We use Abbott Plum A+ pumps. The second issue that we have frequently experienced is the pump not infusing with the set up we have to use (injector/connector/clave). There's a pressure reading on the pump that needs to be below a certain level in order for it to infuse. The addition of the connector seems to raise the pressure and cause the pump not to infuse. The third, and most concerning issue is needle exposure. The addition of the connector makes it difficult to engage and disengage the needle injector from the infusion pump. It's awkward, and it is possible to apply enough twisting force to cause the safety mechanism on the injector to fail, exposing the needle when the device is removed.

We have also experienced tearing of the clave, despite having the connector on. A nurse was exposed to a chemotherapy agent when the membrane tore and the chemotherapy agent sprayed out from the connection. When we try to give an IM injection, the set up is unstable and difficult to use, particularly on an uncooperative patient. Finally, we are not able to use the device to its full potential because we cannot leave a needle connected to a child’s central line when infusing continuous chemotherapy.

Manufacturer response (as per reporter) for enclosed chemotherapy infusion, PhaSeal

Representative came out and spoke with the nursing staff, took photographs, but did not feel they needed the devices themselves. We have retained four devices where the needle was exposed, and the one in which the clave was torn.

Updates from the site:
The clave tearing is a separate issue from the trouble they’ve had disconnecting the device in general and exposing the needle. The clave was torn in the process of connecting the clave to the connector. The IV tubing was hooked into injector. When the pump suddenly stopped infusing, it indicated an occlusion at injector site. The nurse tried to troubleshoot by disconnecting and switching out the injector. When the pump continued to alarm indicating an occlusion again, she disconnected the connector, and chemotherapy sprayed. That’s when it was discovered that the needle had torn the clave.

Comment from FDA: Good example of Human Factors issue.

Device:

Type: Enteral Feeding Set
Manufacturer: Covidien Kendall
Brand: Kangaroo Epump
Model#: (not provided)
Lot #: all lots
Cat #: 773662
Other #: 1000 ml pump set

Problem:
Our institution has been having problems for months with the kangaroo feeding kits not priming consistently. Specifically, it seems to be the white, circular piece encased in a clear purple housing which is sticking (anti-free flow valve?). This piece, which turns, is located at the junction of the tubing from flush bag and the feed bag. The manufacturer is aware, and has suggested that prior to priming the bags, take a key, coin or hemostat and turn the white insert to loosen it. This was suggested as a temporary solution while the manufacturer continues to evaluate ways to correct the problem. We've returned several kits in the past for evaluation. In this particular case, the tubing would not prime, and the entire feeding kit and pump were changed. The nurse turned the valve and the set up appeared to be working. The nurse then bolused the patient with 300 ml fluid and stayed to ensure that the pump and set were working correctly. Instead of water bolusing, tube feed started to bolus. The nurse switched off the pump immediately. There was no patient harm.

See device images
Kendall Kangaroo Full

Kendall Kangaroo Valve


Device:

Type: Infusion Pump
Manufacturer: Smiths Medical MD, Inc.
Brand: Medex 3500 Syringe Pump
Model#: 3500
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
The Syringe pump, under normal operation, loses approximately 1 minute per week from the system clock. This was discovered during repairs and preventive maintenance service in the clinical engineering department. The protocol requires insuring the system clock is correct. After setting the clock during an inspection, it was found that the clock was incorrect after several weeks in-use during the next inspection.

Manufacturer response (as per reporter) for syringe pump, Medex Syringe Pump:

Smiths Medical responded very quickly. They reviewed the issue and stated that the system clock was 'low priority' for the microprocessor and the pump was never designed to be an accurate time keeper. They maintain future software releases will correct the time issue. Wireless pumps will synch with server time each time they communicate.


Device:

Type: Infusion Pump
Manufacturer: Hospira Global Medical Affairs
Brand: Plum Infusion Pump
Model#: Plum XL and Plum XL3
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
To update the drug library on our Hospira Infusion Pumps using Mednet 5.1 software version, a new drug library is sent to the pump over the wireless infrastructure in the hospital. After the pumps receive the new drug library, it is supposed to prompt the user that the new drug library is available when the unit is turned off. Users will often turn on and then turn off a device to initiate the prompt when a device is not in use. It has been found that sometimes the pumps do not prompt when a new drug library is available.

An operator may assume that the infusion pump has the latest version of the drug library because the pump does not prompt that a new version is available. Drug library changes may have different drug limits and/or drug concentrations.

Manufacturer response (as per reporter) for Infusion Pump, Plum Infusion Pump:

The manufacturer has suggested a change to the process of initiating the prompt. Hospira recommended that when the pump is turned on, the user will need to leave it on for two minutes and then turn it off. Alternatively, the user may place a cassette in the unit and then turn it on and then off. When this process was employed, then the pumps consistently prompted the user when a new drug library was available.


Device:

Type: Infusion Pump
Manufacturer: Hospira Global Medical Affairs
Brand: Symbiq
Model#: (not provided)
Lot #: (not provided)
Cat #: (not provided)
Other #: Hospital # 207935

Problem:
The infusion pump was programmed for an Insulin infusion on Channel B of the device, and placed in a standby mode. When the clinician attempted to start the infusion, the pump malfunctioned with error code S421, Subgroup 9, pump bolus overshoot. The malfunction caused a delay in care to a critical cardiac post-operative patient.

The alarm history and event logs were reviewed by our Biomedical Department. Upon powering the device back on, the cassette was removed from Channel B of the infusion pump. However, Channel B would not close and could not be reset. The pump was sent to the manufacturer for analysis.

Prior to the recent recalls, we had reported several similar problems with error codes S321 and S421 which caused delays and interruptions in therapies. However, our pump inventory was swapped out and new software was downloaded to correct the issues we were previously reporting. To our knowledge, this is the first failure of this kind since our pumps were upgraded by Hospira post-recall.


Device:

Type: Infusion Pump
Manufacturer: CareFusion Healthcare Cardinal Health
Brand: Alaris System
Model#: 8100
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
A critical PICU patient was on continuous vasopressors via an infusion pump, including epinephrine and norepinephrine. Without intervention, the channel that was infusing the norepinephrine drip spontaneously beeped and turned itself off reading "Channel Disconnect.” The drip was moved to another channel. Later, during transport to CT scan, two channels (norepinephrine and midazolam drips) also stopped. The patient’s blood pressure dipped slightly, but recovered quickly when the channels were restarted.

Comment from FDA: Please see Class 1 Recall Alaris System Inter-Unit Interface (IUI) Connectors online available: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=82452 and
FDA Patient Safety News (video) - Alaris (Medley) Infusion Systems Recalled – October 2009 online available:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=91#4


Device:

Type: Iv Tubing
Manufacturer: Baxter Healthcare Corporation
Brand: Clearlink System Extension Set
Model#: 2N8378
Lot #: (not provided)
Cat #: 2N8378
Other #: (not provided)

Problem:
IV extension set, Baxter 2N8378 has been noted on several occasions to restrict the flow of IV fluid. This item is used on nearly all IV tubing. In the past couple of weeks, we have had 4 known instances where it greatly restricted the flow by gravity of the fluid. When replaced with another, the flow is much better. On one occasion it was assumed that the IV that had just been established was bad and this malfunctioning piece caused extra IV attempts for the patient, increasing discomfort and risk of infection. When the piece was replaced the problem was solved.


Device:

Type: Iv Tubing
Manufacturer: Hospira Global Medical Affairs
Brand: Lifeshield Plumset Iv Tubing
Model#: 11943-12
Lot #: 770405H
Cat #: (not provided)
Other #: (not provided)

Problem:
Several nurses have reported the threaded connector does not seal properly (the tubing will not screw into the blue port and becomes disconnected easily). It continues to spin as one attempts to establish a tight connection.

Manufacturer response (as per reporter) for IV Plum tubing, (brand not provided):

The manufacturer representative visited the impacted facility to evaluate the reported problem. The representative reported this particular device had been "upgraded" approximately eight months previously, but that it should work the same way. The facility was not aware of the "upgrade" and how and if any changes to the device would cause the device to operate differently.


Device:

Type: Steam Sterilizer
Manufacturer: Getinge
Brand: 733 HC Sterilizer
Model#: 733 HC
Lot #: 05E06109
Cat #: (not provided)
Other #: (not provided)

Problem:
14 trays being sterilized for surgery. 1 tray was wet when opened after 7 other trays from load were used already.

Manufacturer response (as per reporter) for Steam sterilizer, Sterilizer

Reps came out twice to evaluate. Replaced jacket trap and replaced drip leg trap then released unit for use.

Device:

Type: Syringe Pump
Manufacturer: Smiths Medical MD, Inc.
Brand: Medex 3500 Syringe Pump
Model#: 3500
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
A patient was transported from the OR on multiple IV pumps infusing vasopressors. Shortly after anesthesia left the bedside, the IV pump with the carrier fluid for the vasopressors failed with no warning. The patient's blood pressure dropped acutely, and the patient required an Epinephrine spritzer and two fluid boluses of 5% Albumin. The IV pump was quickly changed out, and the patient was stabilized after the pump was changed. The pump did not beep low battery in the ICU or down in the OR per the anesthesiologist. When the pump was plugged in after the event, the readout said 0% battery power. The response time was immediate, and having spare IV pumps in the Clean room is a life saver in these kinds of instances.

Our Biomedical Department evaluated the pump and determined the issue to be related to a defective battery, and the battery will be replaced.


Device:

Type: Temperature Probe, Rectal/esophageal, Single Use
Manufacturer: Cincinnati Sub Zero
Brand: Steri-probe
Model#: 491B
Lot #: D727416
Cat #: (not provided)
Other #: (not provided)

Problem:
The machine operated for approx. 6-8 hours, then "Check Probe" message came on and the machine stopped working in the middle of ECMO therapy.
Additional information obtained from the site:
There are only 2 left from that lot number. The department recently ordered another batch. The sheathing looks different so they may have changed designs or gone to another supplier.
Biomed was made aware of this situation through a repair call and not an occurrence report. the patients' outcome in this case are UNK. We learned that the department had been dealing with this issue for a while and rectifying the problem on the floor by swapping out probes.

Health Professional's Impression:
Original probe was removed from patient and discarded. Another probe from the same lot number was tested by Biomed. It produced the same problem. Further testing revealed that there was a problem with the RJ-11 connector.

Biomed test result:
Biomed initially duplicated complaint under normal setup conditions. Then they cut off RJ-11 and connected directly to cable/device using alligator clips. The device ran for several hours with no problems. Physical examination of the remaining connector revealed that the wires were loosely attached and pulled out easily.


OBSTETRICS/GYNECOLOGY

Device:

Type: Fetal Monitor
Manufacturer: Philips Medical Systems
Brand: Avalon Fm30, Fm50
Model#: FM30, FM50
Lot #: (not provided)
Cat #: (not provided)
Other #: M2736A, M2735A,

Problem:
Fetal monitoring performance problems have been identified by our clinical team. These have been described as:

1. Problems with tracing early gestation fetuses, multiples (twins, triplets). Requiring separate fetal monitors to trace each fetus.
2. Weak FHR (Fetal Heart Rate) signal
3. Loss of FHR signal
4. Doubling/halving of FHR
5. Monitor Volume at maximum level is still not adequate
6. Artifacts present as decelerations
7. FHR tracing is different from actual audible fetal heart rate signal
Patients are in active labor being monitored with external ultrasound fetal monitors. Staff are concerned that the monitors are not projecting an accurate fetal heart rate.Philips stated that they have designed a new algorithm that is currently being tested to fix the monitor incorrect signals issue.

Comment from FDA: For more information please view a FDA Patient Safety News (video) - Inaccurate Readings with Philips Avalon Fetal Monitors – November 2009 online available:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=92#5


PHYSICAL MEDICINE

Device:

Type: Stretcher, Hospital, Electric
Manufacturer: Stryker Medical
Brand: (not provided)
Model#: 1550
Lot #: (not provided)
Cat #: 1550
Other #: (not provided)

Problem:
During venous ultrasound, Pt was placed in extreme reverse trendelenburg. The Stryker model 1550 electric stretcher actually makes contact with its own parking brake release mechanism when the table is placed in a 50-60 degree position and it trips the brake - leaving a patient in a compromised position with the ability for the entire stretcher to free-wheel around the room. This is a risk for patient injury.

Manufacturer response (as per reporter) for Stretcher, Hospital, Electric:

They are looking into it and will be in contact.


RADIOLOGY

Device:

Type: Radiation Shield With Support Arm
Manufacturer: Ti-Ba Enterprises, Inc.
Brand: Mavig
Model#: OT25U50 10KG
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
The metal arm and radiology shield broke off from the machine while the machine was being positioned over the patient. The broken part struck the staff person who sustained only minor injuries.

This is the third arm that has come off a machine.

Device 1:

Type: Ultrasound Gel Warmer
Manufacturer: Ideal Products, Inc.
Brand: (Not Provided)
Model #: GW208
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Device 2:

Type: Ultrasound Gel
Manufacturer: Parker Laboratories, Inc.
Brand: Scan
Model #: Scan
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
Ultrasound gel warmer shorted out and burned the bottles of gel to the warming plate. Smelled like burning rubber.

The gel warmer (Ideal Products) had heated the gel product (Parker Laboratories) to a point where the gel bottles at the top were disfigured (they had expanded) so that the bottles could not be removed without dismantling (unit is held together by rivets which had to be drilled). Upon inspection of the internal components it was noted that on the right hand heating receptacle for the gel bottles the metal tape (used to hold the heating element to the cylinder) had come loose and as such the shielding had become overheated.

The recommendation of the manufacturer in the operation of these units is that the warmer be turned off overnight and on the weekends as some gels and lotions tend to break down and separate when exposed to heat for extended periods of time. We discussed the unit with Ideal and they told me that the unit is equipped with a thermoswitch (rated at 160 degrees) in case the unit overheated.

There are no plans to return the device to the manufacturer. The only sign of heat damage was the wiring which was taped to the receptacles and at points that would be expected during normal operation.

See device images
Gel Warmer

Gel Warmer Bottles



~~~~
Type: Fluid Container
Manufacturer: Ross Pediatrics/Abbott Nutrition
Brand: Similac Glucose Water, Pedialyte, Similac Water
Model#: 34450 FAN 8405
Lot #: Unknown
Cat #: Unknown
Other #: Not applicable

Problem:
The pediatric nursing floor is concerned regarding the packaging of Similac Glucose Water, Pedialyte and Similac Water. All of these products are in identical blue plastic containers/bottles. The labels are different but not distinctively different. The staff are concerned that they will give the wrong product to a patient. They have expressed concern more than once. They would like the packaging changed.

The three items are all the same size, color and all have the same lid. The containers are identical, only the labels differ.

Comment from FDA: Please note that this is product is not a device.

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Medical Device Problem Summaries

Summary of MedSun Reports Describing Adverse Events With Magnetic Resonance Imaging Machine (MRI)

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An MRI machine is a vital diagnostic tool used by clinicians, but it presents some unique safety issues. Patients have been injured when ferromagnetic metal objects have become airborne when drawn toward the magnet's bore and other medical devices have been affected by the MRI's strong magnetic field. Also, some patients have received burns under certain circumstances, caused by the highly intense RF field. These are generally well known risks, largely preventable by vigilant screening of patients, proactive training of users, as well as implementation and observance of safety practices and signage. Nevertheless, FDA continues to receive reports of these occurrences.

Over the past 2 years, MedSun has received 14 adverse event reports associated with the magnetic resonance imaging device manufactured by 5 different firms. These reports were submitted by 10 hospitals between July 2007 and July 2009. The reported device problems were:
• Patient burns (8)
• MRI magnet pulled object across the room (4)
• Patient hearing affected (2)

No reports involved a patient death. The patient injuries listed below were reported in 12 of these 14 reports.
• Patient received burns/swelling (8)
• Patient or Nurse injured by flying metal object drawn in by MRI magnet (2)
• Patient received hearing damage or experienced tinnitus (2)

Of the reports that listed patient age, 1 had a patient age listed as less than 21 years and 10 had a patient age listed as greater than 21 years. Of the reports that listed patient gender, a total of 7 reports involved female patients and a total of 5 reports involved male patients. These MedSun reports contributed to FDA awareness of the device problems.

Adverse Event Table
ManufacturerDevice Device Identifiers Event Description
GE Medical Systems, LLC MRI machine Device model #:1.5T;MR1-734647MR The patient called to complain that she was burned from an MRI 4 days earlier. She had her MRI and called four days later to say she had a red burn on both her shoulders after having her MRI, but didn't let anyone know about it. She said the redness is gone, but there is some swelling on one shoulder. I asked her to contact her PCP and let them know about it. The Tech who scanned this patient didn't know there was anything wrong, because the patient never said anything to her.
Philips Medical Systems MRI machine Unknown IV nurse entered MRI suite and brought her metal IV cart halfway in doorway of MRI suite. The force of the MRI magnet caused the IV cart to lift up and it flew through the air, on to the MRI machine. Patient was lying outside of the MRI, on the MRI table at the time. The cart did not hit him. Another Nurse was on right side of patient and was looking for venous access in his right arm at the time of the incident. She was not injured. No injury for any individual - lots of potential for injury! The IV nurse had been called to access the patient located in MRI. She did not realize the power of the MRI magnet especially when the patient was not in the MRI. She intended to leave the cart at the door, but should not have entered the room. This is being reported not because of a device malfunction but as an alert of an incident regarding an MRI and need for better vigilance and perhaps education regarding the fact that MRI magnets are ALWAYS on and the need for better safety.
Siemens Medical Solutions USA, Inc. MRI machine Unknown Patient had MRI of knee. Used ear protection with no music. Scan went as normal with no indication of problem. Days later the patient contacted hospital and reported hearing damage received during scan. Scan went as normal and no abnormal sounds detected. Patient did not indicate by voice or by facial expressions any discomfort during scan.
Siemans Medical Solutions USA, Inc MRI machine Device model #:7391167; Device catalog #:7391167 Patient from ED room one with MRI wheelchair said she would prefer to go on stretcher. After taking patient to the department, I took out MRI stretcher. Before moving patient to MRI stretcher I had to do MRI screening. Patient was complaining of her pain and said lets get the scan done. I was standing at the head of the stretcher and started to pull it in the room, not remembering patient had not been transferred. By the time I notice the pull on the stretcher it was too late. I was between the stretcher and the magnet. I used my body to reduce the impact. The patient was removed to the MRI stretcher and sent back to the ER.
IGC-Medical Advances, Inc. MRI machine Device model #:415GE - 64A Patient was screened for metal before procedure. No metal found and patient cleared for MRI. Shoulder coil placed on patient and put into magnet. During scan patient felt a shock in his abdomen and burning on shoulder. No metal found anywhere on patient
Philips Medical Systems MRI machine Device model #:ACS Intera Technicians were moving the IV pole and approached the 5 gauss line inside the MRI room. At that time, the IV pole was caught in the magnetic field and started moving toward the MRI machine. Technologist was struck on the arm by the pole as it moved towards the MRI machine.
Invivo Research, Inc. MRI machine Device model #:3155MVS; Took monitored patient out of MRI tube to insert dye. Noticed limb was cyanotic. Removed blanket from patient, and noted that patient was asystole and cyanotic to shoulders. The Invivo monitor showed a heart rate of 146 and pulse oximetry of 93. Invivo monitor continued to show HR of 146 at same time as another monitor showed asystole
GE Medical Systems, LLC MRI machine Device model #:2395001-2 This patient reported while having an MRI procedure, the noise that was transmitted was higher than on previous scans. During the scan, he reports he experienced tinnitus and that the tinnitus has persisted subsequently a month later.
GE Medical Systems, LLC MRI machine Device model #:2226300 Patient had an MRI on his left leg. The body coil was used for this procedure. The patient was properly oriented and padded to avoid contact with the magnet bore wall. When the patient arrived home he noticed two red raised areas (one on his left heel and one on his right wrist). He called the next day to report it to MRI and during the call he noticed the red areas had almost disappeared.
Philips Medical Systems MRI machine Unknown The Intravenous (IV) Team was called to start an IV on a patient who was to undergo a MRI. The IV nurse arrived in the MRI patient holding area with supply items on a wheeled metal cart. The MRI technician questioned the IV nurse regarding possession of any metal inside and outside of his/her body. The nurse removed all metal items and parked the metal supply cart in the patient holding area. Both a MRI supervisor and the technician cleared the nurse (by questioning and checking for any metal objects) before he/she entered the MRI scanning room. The technician and nurse assessed the patient; determined hot towels were needed to place on the patient's arms and left the scanning room to obtain necessary supplies. The nurse went to his/her metal supply cart left in the patient holding area to obtain supplies. As the technician turned to gather the towels, the technician heard a loud bang and crashing sound and observed that the nurse was no longer in the patient holding area. The technician ran into the scanning room and saw that the nurse had brought the metal supply cart into the scanning room and the cart was stuck to the side of the MRI magnet. The technician immediately took action and removed the patient from the scanning room. The patient was not harmed, nor was the nurse. Service was called immediately and the metal supply cart and other metal items were removed from the MRI magnet. A root cause analysis will be conducted.
Siemens Medical Solutions USA, Inc. MRI machine Device model #:7104719 Patient having an MRI prior to radiation therapy treatment. Patient was asked to lie on a carbon fiber and styrofoam positional immobilization board, which is MRI safe. After the scan was completed, the patient reported a burning sensation around their shoulder area. There were three areas of concern: one small black area anterior to two blisters located just posterior to the clavicle.
GE Medical Systems, LLC MRI machine Device model #:1.5T Patient was having a bilateral knee MRI. Because she was so large the pads were not used to protect the patient. The patient's thighs (both)received second degree burns from the MRI because they were touching the MRI bore of the magnet. Silvadene cream applied after incident. Referred to burn center.
Philips Medical Systems MRI machine Device model #:43000-588 Patient reported that he was burned by a "hot" wire under his wrist during an MRI scan. The radiology tech took the patient out of the tube to assess him and did not see evidence of any burn. The patient was re-wrapped with the sheet and placed back into the cylinder. The patient reported again feeling burned, and at the completion of the study, reported his complaint to the nurse on his unit. An area of redness 5 cm by 2cm was noted on his right wrist, and this resolved with lotion. Phillips staff were notified to check the machine. Of note, the patient body habitus was upper limit for MRI accessibility which may have contributed to the proximity of the coil.
GE Medical Systems, LLC MRI machine Device model #:MR1-734647MR Incident occurred on a 300 lb patient. Halfway thru the exam she pressed the emergency button stating that her arms were hot and hurt. I pulled her out and looked at them. They were hot to the touch. Within a minute, the patient stated that the sensation turned to a prickling feeling. Shortly after that the "painful" sensation was gone and it became dull. Once out of the exam room I personally examined her again before she left the building. Much of the redness had gone down. The patient had dark skin so it was difficult to tell the severity of the injury. I am solely going on her physical complaints.



Recall Table
Recall NumberManufacturer Device Recall Number Reason for Recall
Z-1824-2008 Resonance Technology Inc M.R. Vision 2000 Ultra Audio System Headset 2 Potential safety concerns - Use of this product with a MRI may result in the headset's cord overheating and patients experiencing burns to the skin.
Z-1042-2008 Siemens Medical Solutions USA Inc Magnetom Harmony 2 Magnet Quench unintended- magnet of a mobile MRI system quenched into the exam room.




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Summary of MedSun Reports Describing Adverse Events With Brachytherapy Catheters

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Brachytherapy catheters are used to introduce radioactive seeds into cancerous tissue. The seeds are then withdrawn after a predetermined exposure time. They may be used with an automated "after loader" device which contains, loads, and withdraws the seeds as programmed by the user.
Source: American Brachytherapy Society, "About Brachytherapy." Online Available at: http://www.americanbrachytherapy.org/aboutBrachytherapy/history.cfm.
Over the past 2 years, MedSun has received 12 adverse event reports associated with the brachytherapy catheter device manufactured by multiple firms. These manufacturers include Cytyc Surgical Services, Inc., Cianna Medical, Inc., SenoRx, Inc., Best Medical International, Inc., Best Vascular, Inc. and Terumo Medical Corporation. The reports were submitted by 8 hospitals. The most frequently reported device problems were:
• Catheter balloon rupture/leaking (5)
• Catheter tip breaking off in patient (2)
• Catheter had a kink/bent (2)
• Catheter balloon became filled with blood (2)
• Catheter balloon would not deflate/inflate properly (1)

There were no reports involving a patient death. The patient injuries listed below were reported in 4 of these 12 reports.
• Balloon contents mixed with patient biological fluids (2)
• Catheter tip needed removal from patient (2)

Of the reports that listed patient age, 7 had a patient age listed as greater than 21 years. Of the reports that listed patient gender, a total of 11 reports involved female patients and 1 report involved a male patient. These MedSun reports contributed to FDA awareness of the device problems.

[Note: The reports have been edited for clarity]

Adverse Event Table
ManufacturerDevice Device Identifier Description
Terumo Medical Corporation Brachytherapy Glide Catheter Catalog #:CG415; Device Lot #:081212 During a popliteal percutaneous angioplasty with brachytherapy, a piece of the glide catheter broke off in the patient's left femoral artery. A guide wire was in the left femoral artery and a 65cm glide catheter was inserted over the wire. When the physician tried to remove the glide catheter over the wire the glide catheter hung up and became difficult to remove. The glide catheter broke off inside the patient. The surgeon had to perform a cutdown to obtain the foreign body and proceeded with original procedure
Best Vascular, Inc. ICRT catheter Unknown Novoste BetaCath System: the ICRT catheter was kinked so the Sr-90 radioactive train could not be sent back to the device. After the treatment was finished, MD tied to push the Sr-90 radioactive source back to the device, the source left the treatment area and was stuck in the catheter junction outside of the patient's body. MD said the catheter had a kink at the junction. The catheter was pulled out from the patient's body and dumped in a shielded transportation box with whole device. The patient and room was surveyed using radiation survey meter. No radiation was found inside the patient body and in the treatment room of the cardiac cath lab.
Cytyc Surgical Services, Inc MammoSite balloon catheter Device catalog #:2456; Device lot #:08F24HB Patient in OR for re-excision of a right breast lumpectomy. When breast opened, noted MammoSite balloon catheter was ruptured
Best Medical International, Inc. Intravascular Brachytherapy (IVB) source Device model #:SR-90 The patient was being treated with an Intravascular Brachytherapy (IVB) source. Upon completion of the treatment, the source would not retract out of the patient and into the source housing. Emergency procedures were done to attempt to take the device out. The final procedure was to pull the entire IVB and catheter system out of the patient which was done. The system was placed in the emergency box and the IVB was put in a hot lab for storage. The source will be sent back to the vendor for analysis. No obvious injury to patient.
SenoRX, Inc. Brachytherapy Catheter Device lot #:M08091606 The patient had a left axillary sentinel node biopsy and left wire-localized partial mastectomy with complex closure greater than 3mm. Before the cavity was closed, the Mammosite cavity evaluation device was placed into the cavity, instilled with 35ml of saline and US was performed. The ultrasound demonstrated a balloon to skin thickness medial to the incision of 65mm, inferolateral to the incision 50mm and superolateral to the incision 75mm. The balloon was deflated and removed. Subsequently, approximately three weeks post-mastectomy, the patient had placement of a Contura brachytherapy balloon in the left breast at the 2 - o'clock position with no complications. A simulation note, four days later, states that the balloon had been filled with 30ml of saline and 1ml of contrast to help with imaging. 3mm axial slices were taken of the breast. The images were sent to the treatment planning system and evaluated. It was apparent that the seroma in the superior position of the breast superior to the Contura balloon remained intact with very little resolution. Evaluation of the lumpectomy cavity was that it was too far distant from the surface of the Contura balloon due to the seroma. It was determined that she was not a candidate for partial breast radiation using that balloon. The balloon was pulled 5 days after initial placement, and the fluid extracted from the balloon was bloody and cloudy. The catheter was found to not be appropriate for the intended therapy and therefore was discontinued. The fluid in the balloon was found to be bloody and cloudy. Documentation indicates that 1 ml of contrast had been added to the 30 ml of saline which accounts for the cloudiness but not the bloody appearance.
SenoRx, Inc. Balloon Catheter Other device #:B011-45 The balloon applicator had blood in the radiation ports. This is not appropriate since it can contaminate the high dose rate brachytherapy device which is used on multiple patients at a time. The manufacturer's representative was present. This is a known manufacturing error that has occurred in 2 out of 1000 cases. The balloon was pulled and replaced with a different type of device.
Cytyc Surgical Services, Inc. Mammosite Balloon Catheter Device lot #:07F20H Patient had Mammosite CT planning. When patient returned the next day for first treatment, she stated the balloon had burst. She did call her physician's office that night and they stated that was probably what happened. We then took her into the HDR (High Dose Radiation) suite and verified it with a C-Arm
Cytyc Surgical Services, Inc. Mammosite Balloon Unknown Patient reported to us that she heard a popping noise the day before; she thought the mammosite balloon had burst. We did a CT scan and this confirmed that the balloon had burst. New catheter was put in.
Cytyc Surgical Services, Inc. Mammosite Balloon Device lot #:06E09 Two mammosite balloon catheters placed were defective. First placement burst in the night; second placement, three days later deemed to be asymmetrical upon evaluation in Radiation Oncology and had to be removed.
Nucletron Source Position Simulator Part #:111.094 The patient had been simulated for high dose partial breast radiation of short duration. When the patient returned for her second treatment, the catheter measurements, measured by Nucletron source position simulator, were different than for the first treatment. Investigation showed an obstruction or kink in the Source Position Simulator, and an error in the measurement of length during the initial treatment where the radioactive source should reside within applicator system. The remaining dose was adjusted, and the patient was not injured.
Cianna Medical, Inc. SAVI Catheter Unknown Image guided placement of a partial breast radiation brachy catheter device was planned. The cavity was measured at 5.87cm x 2.32cm and was somewhat irregularly shaped, but the seroma cavity was well visualized. A laparoscopic trocar device was used to dilate the tract and a SAVI 8.1 breast applicator device was inserted under direct vision. When the struts were deployed there was quite a bit of resistance met. The catheter was removed and inspected. The catheter had deformed from the scar tissue within the cavity since the cavity was approximately 8 weeks old at the time. A balloon applicator was filled with 30ml of sterile saline and used to dilate the seroma cavity. The catheter was allowed to dwell in the seroma for several minutes and the saline was evacuated. A fresh Savi 8.1 device was then applied. The new catheter was applied under US guidance into the seroma cavity. It went in easily and seemed to deploy well. The applicator was turned four complete revolutions to partially deploy the device. Placement was verified using US in a transverse orientation and the struts were partially deployed as expected. The following day the patient was called back for additional CT simulations with treatment planning. Based on the CT imaging, the catheter was expanded when it was determined that it was not fully expanded originally. No problem were reported with that expansion. However, they did see that multiple struts were inverted which required a recommendation to remove the device. The doctor attempted to take the struts down but the catheter was completely jammed and the apparatus was not functioning properly. The SAVI physicist was present and witnessed that the device did not deflate properly. The doctor did remove the device at that time when it was determined that it would slide out, rather than take the patient to surgery. The patient was medicated with morphine and the area was closed with steri-strips. A small area of ecchymosis developed at the site but there was no sign of infection. This event was reviewed by radiation physicists at this facility who stated: it is possible that the time period between the lumpectomy and the catheter implant may have exceeded the recommended time limit. It was noted that identification of the catheters on CT was difficult because some were inverted. The catheter inversions may have been caused by the fibrotic cavity. The cavity was contoured on Pinnacle and the estimated volume was 91.5 cc which exceeds the recommended limit (90.0cc)of the largest (10-1) SAVI implant and this was communicated to the manufacturer. The manufacturer told the medical providers at our facility that, among other things, the cavity may shrink so this was not a concern. It had been 8 weeks since the lumpectomy was performed, at the time the catheter was placed, which exceeded the 6 week recommended limit. Two manufacturer's reps were present and assisted during the implant. The day after the implant the patient was scanned and the images were transferred first to Pinnacle and then to Brachyvision for planning. A physician from Cianna was present to assist. This was our facility's first SAVI case. CT images showed the inverted catheter struts, probably caused by the length of time between surgery and insertion of the catheter. Attempts were made to make sure the device was fully expanded and a rep from Cianna was present to help with that. Rescanning showed that the struts were clustered and couls not be individually identified. Another rep from Cianna informed the providers that the case couls not be planned and the catheter was to be removed. The expansion tool was rotated by the doctor to collapse the implant and external inspection and lack of resistance gave the appearance that it had collapsed. The implant was pulled out, but following inspection after removal, it was clear that it had not collapsed. The catheter was given to the manufacturer's rep. No packaging was kept by the hospital, and no identifying information was recorded.
Cytyc Surgical Services, Inc. MammoSite Balloon Device model #:2056; Device lot #:07F20H A spherical MammoSite balloon was being inserted under ultrasound blood guidance into the right breast. The balloon was placed and then saline was infused. During the infusion, the balloon began to leak and saline spilled out. The balloon was removed and a second one was placed. There was no harm to the patient as a result of this incident.





Recall Table
Recall NumberDevice Manufacturer Recall Class Reason for Recall
Z-1020-2009 TheraSeed Spacers Theragenics Corporation 2 Some pouches were found to have weak seals potentially compromising sterility.
Z-0921-05 Flexible Implant Tube; part # GM11003730 Varian Medical Systems 2 A defective treatment applicator in a cancer therapy medical device may become separated potentially causing patient injury.


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Updated December 1, 2009

Return to MedSun: Medical Product Safety Network

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