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U.S. Department of Health and Human Services

MedSun: Newsletter #59, April 2011

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Newsletter #59, April 2011

Articles

Triad Alcohol Prep Pads, Alcohol Swabs, and Alcohol Swabsticks: Recall Due to Potential Microbial Contamination

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FDA MedWatch Safety Alert

Eli Lilly and Company notified customers not to use Prep Pads in black starter kits for Forteo [teriparatide (rDNA origin) injection].

Additional Information:

FDA MedWatch Safety Alert. Triad Alcohol Prep Pads, Alcohol Swabs, and Alcohol Swabsticks: Recall Due to Potential Microbial Contamination. March 23, 2011.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm239319.htm

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Recall - Firm Press Release: Millar Instruments, Inc. Issues a Recall of Millar Mikro-Tip Angiographic Catheter, Model SPC-454D and SPC-454F

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Recall - Firm Press Release

Millar Instruments, Inc., is issuing a worldwide recall of 1,080 units of its Human Use High Injection Angiographic Catheter. The Angiographic Catheter, Models SPC-454D and SPC-454F, found to contain particulate debris within the catheter lumen, which potentially could result in embolization of foreign debris to tissues, vasculature, and organs, potentially causing myocardial infarction, stroke, limb ischemia, and /or death.

Additional Information:

Recall – Firm Press Release. Millar Instruments, Inc. Issues a Recall of Millar-Mikro-Tip Angiographic Catheter. March 21, 2011.
http://www.fda.gov/Safety/Recalls/ucm247945.htm

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H & P Industries Povidine Iodine Prep Pads: Recall - Potential Microbial Contamination

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FDA MedWatch Safety Alert

H&P industries, Inc., a manufacturer of over-the-counter products, initiated a voluntary product recall of all lots of Povidine Prep Pads manufactured by H&P Industries, Inc. but which are private labeled for many accounts. Analytical testing showed the presence of Elizabethkingia meningoseptica. Use of contaminated Povidine Prep Pads could lead to life-threatening infections, especially in at risk populations, including neonates, immune suppressed patients, and surgical patients. Treatment options are limited for Elizabethkingia meningoseptica infections.

Additional Information:

FDA MedWatch Safety Alert. H & P Industries Povidine Iodine Prep Pads: Recall - Potential Microbial Contamination. March 18, 2011.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm247743.htm

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Gen-Probe Inc., AccuProbe Group B Streptococcus Culture Identification Test, AccuProbe Mycobacterium Tuberculosis Complex Culture Identification Test and, AccuProbe Mycobacterium Avium Complex Culture Identification Test: Class I Recall

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FDA MedWatch Safety Alert

The affected kits may contain tube components that are partially empty or empty of solution. Possible false-negative results may occur. This may cause serious adverse consequences and/or death. Gen-Probe is recommending that customers discontinue using the identified batch (lot) numbers. For customers who used these batches and obtained negative results, the firm recommends that the referring physician be notified about the possibility of a false negative result.

Additional Information:

FDA MedWatch Safety Alert. Gen-Probe Inc., AccuProbe Culture Identification Tests: Class I Recall. March 17, 2011.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm247569.htm

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'Smart' Infusion Pumps are Selectively Intelligent

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FDA Medical Device Safety

In recent years, "smart" infusion pumps have become increasingly sophisticated and include such features as close error reduction software, commonly referred to as drug libraries. However, these smart pumps can't prevent all programming and administration errors. Clinicians must use professional judgment and adhere to established standards of care and standard operating procedures for safe medication administration when using this or any other technology.

Additional Information:

FDA Medical Device Safety. “Smart” Infusion Pumps are Selectively Intelligent. March 10, 2011.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm245160.htm

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Roche Insulin Delivery Systems announces recall of ACCU-CHEK FlexLink Plus infusion sets

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FDA Press Release

Roche Insulin Delivery Systems announced today that it is notifying its customers and healthcare professionals about the recall of the ACCU-CHEK® FlexLink Plus infusion set, because of the potential for under delivery of insulin due to a kinked/bent cannula when inserting the ACCU-CHEK FlexLink Plus infusion set. If this remains unnoticed, this can result in under delivery leading to elevation of blood glucose levels.

Additional Information:

FDA Press Release. Roche Insulin Delivery Systems announces recall of ACCU-CHEK® FlexLink Plus infusion sets. February 21, 2011.
http://www.fda.gov/Safety/Recalls/ucm244487.htm

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Cook Inc., Single, Double, Triple and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripheral Inserted Central Venous Catheter Trays

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FDA MedWatch Safety Alert

FDA notified healthcare professionals of leaks in the plunger Luer detected during a routine syringe leak test. The potential exists for leakage and possible loss of sterility. This may lead to serious adverse health consequences and/or death. Customers were asked to examine their inventory and notify Cook about returning the recalled products.

Additional Information:

FDA MedWatch Safety Alert. Cook Inc., Single, Double, Triple and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripheral Inserted Central Venous Catheter Trays. April 3, 2011.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm245634.htm

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Davol XenMatrix Surgical Graft: Class I Recall - Elevated Endotoxin Levels

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FDA MedWatch Safety Alert

FDA notified healthcare professionals that several lots of XenMatrix Surgical Graft have been found to have elevated endotoxin levels. Endotoxins (pyrogens) are substances found in certain bacteria that, at elevated levels, can cause serious illness which can be fatal. Customers should contact Davol Customer Service for instructions on how to return the products.

Additional Information:

FDA MedWatch Safety Alert. Davol XenMatrix Surgical Graft: Class I Recall - Elevated Endotoxin Levels. March 4, 2011.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm245720.htm

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HeartNet

ConMed Tru-Link Neotrode Recall

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FDA Medical Device Recalls

Poor signal or loss of signal. Certain recalled devices have a loose wire attachment that may lead to intermittent or poor signal quality. MedSun has received a report with this device. To read the event, please see the link provided in Additional Information below.

Additional Information:

FDA Medical Device Recalls. ConMed Tru-Link Neotrode Recall. March 2, 2011.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=97513

MedSun Report. MedSun Website. June 21, 2010.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/medsun_details.cfm?ID=%25%22%5DS%3A%26%2FH%20%0A&CFID=55680617&CFTOKEN=f77b53d0714a861e-B5ACE

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HomeNet

Home Use Devices - Featured Case Studies

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FDA Medical Device Safety

FDA's Home Use Device website provides resources and safety information about medical products used in the home environment. This website now features 'Case Studies of the Month' that showcase reported problems consumers and health care professionals experience with their medical device. The FDA encourages consumers and health care professionals to report problems they have with their devices while they are using them. This could be anything from an injury or death to a malfunction or near miss with a device while it is being used. To see these case studies, visit the links in additional information below.

Additional Information:

FDA Medical Device Safety. Home Use Devices – Featured Case Studies. March 3, 2011.
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/HomeUseDevices/ucm238841.htm

FDA Home Use Device Website.
http://www.fda.gov/homeusedevices

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KidNet

MedSun's KidNet - A Model for Patient Safety

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Suzanne Rich, RN, FCN, MA, CT
MedSun/OSB Division of Safety Partnerships


KidNet is a specialty subnetwork of FDA's Medical Product Safety Network (MedSun). It focuses on identifying, understanding, and solving problems with medical devices used in neonatal and pediatric patient populations, especially those occurring in neonatal and pediatric intensive care units (NICUs and PICUs).

The goals of KidNet are: (1) to improve the recognition, reporting, and understanding of device-related adverse events occurring with pediatric patients, especially those in NICUs or PICUs, and (2) to develop a clinical community to validate signals of actual or potential medical device problems affecting NICU or PICU patients. This concept is based on collaboration and communication between FDA, KidNet participants, and device manufacturers, in order to better understand device safety and to identify solution and prevention strategies to address identified problems.

Currently, 48 of the 350 MedSun nationwide network of hospitals are participating in KidNet. A little over a third of these are MedSun pediatric hospitals; the rest are MedSun hospitals with NICUs and PICUs. We launched KidNet in June 2007. Although the focus of KidNet is on device-related problems occurring in the NICU or PICU, reports of ‘near-miss’ or ‘close-call’ events, and events representing ‘a potential for harm’ involving pediatric patients that occur in other areas of the hospital are also welcome.

For calendar year 2010, MedSun, from the entire complement of participating hospitals, received a total of 556 reports from 100 hospitals involving pediatric patients (those with ages less than 21 years).

Of these, 108 are from sites participating in KidNet; reports were received from 32 of the 48 KidNet hospitals. This represents an increase in both the number of KidNet reports and the number of KidNet hospitals submitting reports; 62 reports were received from 21 of the 42 MedSun hospitals participating in KidNet during 2009. The data discussed in this article are derived from the 108 KidNet reports received in 2010.

 This bar graph illustrates the number of KidNet reports received by quarter.  These reports were submitted by KidNet participant sites over the 2010 calendar year.  The 108 KidNet reports have been grouped by quarter (1st quarter, 2nd quarter, 3rd quarter, 4th quarter). The x-axis corresponds to quarter; the y-axis corresponds to the number of reports.  Left to right description of image: of the 108 KidNet reports received in 2010, the light purple data point shows that 15 KidNet reports were received in the 1st quarter.  The burgundy data point shows that 29 KidNet reports were received in the 2nd quarter.  The yellow data point shows that 35 KidNet reports were received in the 3rd quarter.  The tallest data point, depicted by a light blue bar shows that 29 KidNet reports were received in the 4th quarter.

As part of the larger MedSun network, KidNet emphasizes the importance of device users recognizing and reporting device related adverse events that occur in NICUs and PICUs. To this end, we provided learning opportunities for MedSun KidNet hospitals through on-site presentations for healthcare professionals working in NICUs and PICUs to raise their awareness of the need to identify and report device-related problems for those vulnerable patients. We plan to continue offering learning opportunities via webcast to those KidNet hospitals that weren’t able to participate in the on-site presentations during 2010.

All but three of the 2010 reported events from KidNet involve device-related problems described as minor harm, potential for patient harm, or close call events. Three reports indicate that intervention was required to prevent permanent impairment or damage (FDA’s definition of serious injury). There were no KidNet reported events in 2010 associated with a patient death.

 This pie chart illustrates the number of reports by event type submitted by KidNet participant sites in 2010.  The 108 reports are categorized by event type, specifically by the categories of:  device problems, serious injury, and death.  Of the 108 reports, 105 reports were submitted as product problems, depicted by a light purple pie wedge.  3 reports were submitted as serious injury and 0 reports were submitted as death, which is depicted by burgundy and yellow pie wedges, respectively.

The three reports describing serious injury events (those requiring medical or surgical intervention taken to prevent permanent impairment or damage) involve a peripheral IV catheter, a peripherally inserted central venous catheter (PICC), and a neonatal electrocardiograph electrode. Both events with the catheters cite leaking at the catheter hub requiring catheter removal. The PICC catheter broke upon removal, necessitating surgical removal of a retained catheter fragment. The event involving the neonatal electrocardiograph involves a burn mark noted when the electrode was replaced.

The 108 KidNet reports reference 124 devices, of which there are 41 different types. The number of devices is greater than the number of reports as more than one device may be referenced in a report. The 41 reported device types have been grouped into 6 clinical medical specialty areas as defined below for the chart that follows.

(1) IV devices –
IV tubing, PICCs, infusion pumps, umbilical artery catheters, short term peripheral IV catheters, central venous catheters, implanted ports, thermal infusion fluid warmer, infusion line filter

(2) CV/Neurology devices -
EKG electrodes, cardiopulmonary bypass devices, thermal regulating systems, physiological monitor, blood pressure monitor transducer, central nervous system shunt, intracranial pressure monitor

(3) AN/Respiratory devices –
high frequency ventilators, tracheostomy tubes and cuffs, oximeters, respiratory humidifiers, ventilator tubing, nebulizer, tracheobronchial suction catheter, anesthesia gas machine, manual emergency resuscitator

(4) All other reported devices –
implantable staple, electrosurgical cutting and coagulation devices, bronchoscopes, arthroscopes, patient data software, flotation therapy mattress, blood lancet

(5) Neonatal/pediatric devices- infant heel warmers, neonatal transport incubators, liquid medication dispenser, circumcision clamp, infant radiant warmer

(6) GI/GU devices – dialyzers, gastrointestinal tubes, genitourinary catheter accessories, feeding tube

 This bar graph illustrates the number of reported medical devices by type in 2010 KidNet reports. The 124 devices reported have been grouped by clinical medical specialty. The x-axis corresponds to type of device; the y-axis corresponds to the number of reports in descending order.  Left to right description of image: of the 124 devices reported in 2010, the tallest data point, depicted by a light purple bar, shows the number of reports that involve Intravenous (IV) devices.  The burgundy data point shows the number of reports that involve Cardiovascular/Neurology devices.  The yellow data point shows the number of reports that involve Anesthesiology/Respiratory devices.  The light blue data point shows the number of reports that involve All Other device types.  The dark purple data point shows the number of reports that involve Neonatal/Pediatric devices and the peach data point shows the number of reports that involve Gastroenterology/urology devices.

Reported patient demographics include patient age and gender. Patient gender was provided in 87 of the 108 KidNet reports. There are almost twice as many reports involving males as females.

 This pie chart illustrates the number of 2010 KidNet reports that specify patient gender.  The 87 reports are categorized by gender, specifically by male and female.  Of the 87 reports, 56 reports involving male patients were submitted, which are depicted by a light purple pie wedge.  31 reports involving female patients were submitted, which are depicted by a burgundy pie wedge.

The patient ages provided in 85 of the 108 KidNet reports range from 1 day to 21 years with the majority involving patients 0-30 days old.

The chart below groups patient ages by the pediatric subpopulations specified in the Guidance for Industry and FDA Staff: Pediatric Expertise for Advisory Panels online available at: http://www.fda.gov/cdrh/ode/guidance/1208.html.

 This bar graph illustrates the number of reported patient ages by pediatric subpopulation in 2010 KidNet reports. The 85 reported patient ages have been grouped by pediatric subpopulations.  The x-axis corresponds to pediatric subpopulation; the y-axis corresponds to the number of reported patient ages.  Left to right description of image: of the 85 reported patient ages in 2010, the tallest data point, depicted in light purple shows that 43 reports involve newborn patients (0-30 days).  The burgundy data point shows that 19 reports involve infant patients (30 days-2 years).  The yellow data point shows that 6 reports involve child patients (2 years-12 years).  The light blue data point shows that 17 reports involve adolescent patients (12-21 years)

Information on the device user was provided in 57 of the 108 KidNet reports with the nurse most frequently cited as the device user and family members least frequently noted as using the device in the report.

 This pie chart illustrates the number of reports by device users - who was operating the device at the time of the event – in 2010 KidNet reports. 57 KidNet 2010 reports indicate the device user.  The largest segment in light purple shows that nurses were operating the reported device at the time of the event.  The burgundy segment shows that doctors were operating the reported device at the time of the event.  The yellow data point shows the reports that identify other allied health providers as the user operating the reported device at the time of the event.  The light blue data point indicates that a family member was using the device at the time of the event.

In the fall of 2010, KidNet sponsored a webcast on PICC and Umbilical Catheter Safety featuring educators from participating MedSun KidNet hospitals. The webcast discussed how to optimize patient safety when inserting and maintaining peripherally inserted central venous catheters (PICCs) and umbilical catheters in the neonatal patient. Examples of medical device adverse events with safety tips to manage and prevent problems associated with PICCs and umbilical catheters in the neonate were also presented.

Printable presentation slides and a video of the slide presentation are available for this webcast online at: http://www.fda.gov/MedicalDevices/Safety/MedSunMedicalProductSafetyNetwork/ucm234684.htm.

Additional educational materials from prior MedSun KidNet programs are available online at: http://www.fda.gov/MedicalDevices/Safety/MedSunMedicalProductSafetyNetwork/ucm112724.htm.

Reporting medical device problems seen in the neonatal and pediatric clinical settings promotes patient safety. MedSun KidNet reports are associated with manufacturer actions taken to address device problems including leaking catheter luer hubs, smoking infant warmers, monitor screens spontaneously blanking, and patient burns associated with neonatal transilluminators used to locate veins for vascular access.

If you become aware of problems with devices indicated for use with neonatal or pediatric patients that fail or don’t perform as intended, or represent a potential for harm, please report these events through your MedSun representative if you’re a member of KidNet or MedSun, or through your hospital’s reporting policy. If you are not affiliated with a MedSun hospital, you can submit a voluntary report online through MedWatch at http://www.fda.gov/medwatch/index.html. Together, we can make recognition and reporting of actual and potential medical device-related problems a model for patient safety.

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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 January 1 through January 31 2011. 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: Endotracheal Tube
Manufacturer: Medtronic XOMED Inc.
Brand: Nim Emg
Lot #: 69371500
Cat #: 8229306

Problem:
Upon removal of Medtronic XOMED NIM EMG Endotracheal Tube from the packaging, it was noted to have a red wire fault. The device was not used on the patient.


Device:
Type: High Flow Heat And Humidification Device
Manufacturer: Vapotherm Inc
Brand: Precision Flow

Problem:
Vapotherm alarmed, indicating a problem with the disposable water path. Unit was not delivering flow, so supplemental oxygen was given during this time. Vapotherm water path was changed out along with the circuit. User continued to receive faulty water path alarm. Also unit was not delivering flow. Unit was completely changed out.


Device:
Type: Video Laryngoscope
Manufacturer: Verathon Inc
Brand: Glidescope
Model#: Ranger
Lot #: 0125-0495-00-51
Other #: rm072326

Problem:
While the MedEvac crew was preparing to intubate a patient on a scene call, the Glidescope's screen initially had a clear screen but then became very grainy and then faded to black and would not turn back on. Instrument was then set aside and not used on patient. Crew proceeded with intubating the patient without the scope. After patient care, crew member placed the Glidescope back on the charger. The next shift's crew attempted to turn the scope on but it would not turn on and screen remained black.


CARDIOVASCULAR

Device 1:
Type: Cable, Connector
Manufacturer: Biosense Webster
Brand: Redel Cable
Cat #: C10MRMSTKS

Device 2:
Type: Cable, Extension
Manufacturer: St. Jude Medical
Brand: Response
Lot #: 3195384
Cat #: 401661

Device 3:
Type: Catheter, Ablation, Cardiac, Rf
Manufacturer: Biosense Webster
Brand: Navistar Thermocool
Model#: N175TCFH
Other #: REF # 34H57M

Device 4:
Type: Catheter, Mapping
Manufacturer: St. Jude Medical
Brand: Reflexion Hd
Lot #: 3210542
Cat #: D402864

Device 5:
Type: Generator, Ablation, Cardiac, Rf
Manufacturer: Biosense Webster
Brand: Stockert

Device 6:
Type: Computer, Diagnostic, Cardiac, Mapping
Manufacturer: Biosense Webster
Brand: Carto Xp

Problem:
The connector for a Biosense Webster Navistar Thermocool ablation catheter fit into a SJM Reflexion HD catheter. This led to the Reflexion HD being directly attached to the Stockert generator. The connector of both the Reflexion HD as well as the Navistar Thermocool has the same type of "end" that allows it to be connected to either catheter. The other end of the connector is very different for each catheter. The Reflexion HD has "tails" while the NaviStar has a "redel" connector. Unfortunately, the end of the connector was not observed by the physician before the connection was made since it was hidden by the sterile drape.

Even though RF energy was not delivered, the Stockert generator, which sends out 50hz signals @ baseline sent energy through the Reflexion HD catheter which resulted in the heating of blood in the left atrium which appeared as echo contrast "bubbles" on the ICE catheter. Additionally, the ECG signal was abnormal due to the incorrect connector. Once both these issues were identified by the physician, the procedure was aborted, all catheters removed and the patient evaluated for sequelae. The patient developed no apparent problems due to this incident. After the procedure, the physician did a "bench test" of the same catheter set up that was in the patient and was able to reproduce the same "bubbles" in a water bath.
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Health Professional's Impression
======================
By connecting the Reflexion HD to the Stockert generator, "energy" was delivered even though the RF delivery button was not pushed. This was probably due to the fact that the Stockert generator always sends out a 50 HZ signal when the machine is turned on in the standby mode. This "energy" heated the blood in the patient's left atrium and caused the "bubbles" the physician saw on echo.
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Manufacturer response for Connectors, Reflexion HD and Biosense NaviStar Thermocool catheter and Stockert generator
======================
They asked about details of situation as well as patient condition.

See device images:

Image of Thermocool Connector

Image of St Jude and Biosense Connector Ends


Device 1:
Type: Cable, Temporary Pacing, Disposable
Manufacturer: Remington Medical, Inc
Brand: Disposable Screw-down Extension Cable
Model#: FLl-601-97
Lot #: 102717

Device 2:
Type: Pacemaker, External
Manufacturer: Medtronic, Inc.
Brand: 5388 Dual Chamber
Model#: 5388

Problem:
The patient had a temporary pacemaker from a prior CABG surgery 3 days ago. The patient was scheduled for permanent pacer insertion. At the time the MD was placing the permanent pacemaker lead into the chest, the temporary pacer quit working and the patient flat lined, requiring immediate chest compressions. The permanent pacemaker lead was placed and the patient started capturing the pacemaker rhythm.

The MD notes from the operative report read: "The permanent ventricular lead was passed into the ventricle. At the time that it was tested, the patient became asystolic. The temporary pacemaker at that time was not pacing either and chest compressions were carried out while the ventricular wire was being placed and the screw was activated on the ventricle. At this time the patient proceeded to capture and the ventricular lead threshold was tested down to 1.5 millivolts and felt to be adequate with adequate resistance. Following this, the permanent pacemaker generator was placed on the permanent ventricular lead and the permanent atrial lead was then placed and tested. The P-wave on the atrial lead was 2 millivolts and active fixation was used to fix that. The permanent pacemaker was a Medtronic Adapta, model #ADDR1 was implanted in the pocket and secured with a stitch. The pocket was then closed in three separate layers." The permanent pacemaker insertion was completed and the patient tolerated the entire procedure satisfactorily and left the operating room in stable condition.
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Health Professional's Impression
======================
The RN who wrote the report wrote "It was noted the temporary ventricular wire does not stay snuggly fit within the temporary pacemaker device. It is also noted that within the external pacer device is a 3 prong connection whereas the pacing cables are 2-pronged. The atrial cable appears to be fitting correctly without issue."

See device images:

Image of Temporary Ventricular Cable

Image of Pacemaker connector


Device 1:
Type: Catheter, Intravascular, Diagnostic
Manufacturer: AngioDynamics Inc
Brand: Soft-vu Omni Flush
Lot #: 511742
Cat #: 10732204
Other #: 5F 90cm

Device 2:
Type: Catheter, Intravascular, Diagnostic
Manufacturer: AngioDynamics Inc
Brand: Soft-vu Omni Flush
Lot #: 511742
Cat #: 10732204
Other #: 5F 90cm

Problem:
Device had just been opened but broke in preparation of procedure. A second identical device was opened and the same issue occurred (both were set aside before being used on patient so no patient harm occurred with the exception of a slight delay in procedure). A third identical device was opened and was successfully used with patient. Prep and drape of both groins; micropuncture technique was utilized to access the left common femoral artery without difficulty. A 5Fr sheath was then introduced followed by an omniflush catheter and with this we were able to successfully cannulate the right iliac system with an angled 0.035 Glidewire".
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Health Professional's Impression
======================
Nurse who handled the three devices said the first two essentially fell off upon opening of the packages and the third was fine and was used in procedure.


Device:
Type: Compressor, Cardiac External
Manufacturer: Zoll Medical Corporation
Brand: Autopulse
Model#: Model 100

Problem:
The AutoPulse device was initiated for chest compressions during resuscitation. The AutoPulse device functioned for approximately 5 minutes before it quit. Manual compressions were then initiated. The battery was replaced and the AutoPulse used again but the device only operated for 2-3 minutes. Manual compressions were resumed and used for the duration of resuscitation.


Device:
Type: Coronary Drug-eluting Stent
Manufacturer: Boston Scientific
Brand: Taxus Liberte Monorail
Model#: 38936-3235
Lot #: 13114285
Other #: 32mm Stent System

Problem:
Balloon at the end of catheter did not inflate. When the physician attempted to remove catheter, it became stuck at the sheath. Physician advanced catheter in an attempt to release stent. When unsuccessful, the physician removed the delivery system and the balloon was noted to have broken off system. The balloon and stent remained in the vessel. The balloon and stent were retrieved from within patient using a snare device. The patient tolerated the procedure, but a stent was never placed.
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Health Professional's Impression
======================
Balloon did not inflate and then broke off the delivery system while in vessel.


Device:
Type: Defibrillator External Paddle Set
Manufacturer: Philips Medical Systems
Model#: M3542A
Cat #: M3542A

Problem:
Top covers of the paddle handle separates from either the sternum or the apex handle.


GENERAL & PLASTIC SURGERY

Device:
Type: Clip Applier
Manufacturer: Ethicon Endo-Surgery
Brand: Ligamax 5
Model#: EL5ML
Lot #: G4UA0G
Cat #: EL5ML

Problem:
During an endoscopic procedure a multiple clip applier jammed while surgeon was working in patient's abdomen. Surgeon stated clip applicator jammed and he was unable to disengage the jaw in order to release the vessel. He had to pull the device off of the vessel which caused some shearing to the vessel wall.
======================
Manufacturer response for 5mm Endoscopic Multiple clip Applier, Ligamax 5
======================
Return to manufacturer for analysis in pre-paid return carton. Manufacturer to provide our hospital with analysis report.


Device:
Type: Tray, Surgical
Manufacturer: Medline
Brand: Medline Sterile Laceration Tray
Lot #: 10IB4116
Cat #: DYNDL1228

Problem:
We are reporting a total of 10 devices of the same lot and from the same manufacturer with this one report. MD reports that he opened a laceration tray and had difficulty opening and closing the hemostat needle holder in the kit. Another tray was opened and the same difficulty was encountered. There appears to be nothing wrong with the device visually. There are no problems with any of the other contents of the tray. A total of 10 laceration trays were found with this same problem. All were from the same lot number. The 11th tray that was opened had no difficulties. As expected, the hemostat needle holder opened and closed smoothly without difficulty. The 11th kit also was from the same lot number. None of the affected devices came into contact with the patient and there was no patient harm involved in this event.
======================
Health Professional's Impression
======================
The staff feels that the bolt/screw used to keep the two pieces of the device together may have been put on too tightly.
======================
Manufacturer response for Needle holder hemostat, Medline sterile Laceration Tray
======================
Manufacturer was contacted. We are currently awaiting return instructions and plan to send the device back to the manufacturer for their inspection and analysis.

Device:
Type: Sponge, Gauze
Manufacturer: Covidien
Brand: Vistec
Model#: 7318
Lot #: 100000153962

Problem:
Black "metal" appearing fleck on tape around sponges inside of the sterile packaging noted on room set-up.

See device image:

Image of black debris appearing fleck on tape around sponges inside of the sterile packaging noted on room set-up.



GENERAL HOSPITAL

Device:
Type: Catheter, Picc
Manufacturer: Navilyst Medical
Brand: Xcela (Custom Kit)
Lot #: 4073476 & 4076684
Cat #: 60M210407

Problem:
Staff discovered that there is "communication" between the lumens in our dual lumen PICC line kits. The fluids are commingling between the two lumens when fluids are pushed through the hub of product. The device in some form or fashion has become compromised and is leaking fluid to the other lumen.
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Health Professional's Impression
======================
The device in some form or fashion has become compromised and is leaking fluid to the other lumen.
======================
Manufacturer response for Dual Lumen PICC LIne Kit, Xcela (Custom Kit)
======================
The manufacturer is planning to examine the PICC lines that have been explanted. They will also take samples of the new product from the lots in question and test for infiltration/compromise.


Device:
Type: Port, Implanted, Catheter
Manufacturer: AngioDynamics
Brand: Vortex Tr Vascular Access Port
Model#: SSAX-16-1

Problem:
Five months ago a port (Angiodynamics 9.6 FR model SSAX-16-1) was removed from a patient who had completed cancer treatment. Unbeknownst to the surgeon at the time, the strain relief sleeve was retained subcutaneously in the soft tissue of the patient's left upper chest wall. The strain relief sleeve is a piece of silicone tubing about 2cm long that fits over the connection of the port reservoir stem and the catheter. No record could be located for the port lot number. However at the time the operating room was using the above model for that size port exclusively in patients on the pediatric service. Recently the surgery team was first made aware that the patient was complaining of discomfort from an object under the skin medial and adjacent to the port incision scar. The shape of the object matches the size of the catheter sleeve seen on the chest x-ray.


NEUROLOGY

Device:
Type: Cap, Cooling, Infant
Manufacturer: Natus Medical
Brand: Cool Cap

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Problem:
Infant in re-warming phase when cool cap machine made a "pop" noise. A burning smell was noted near the machine and the screen went black. The device was immediately unplugged from the wall outlet. All probes were removed from the infant and away from the bed. Infant was placed on cooling blanket to continue therapy.
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Health Professional's Impression
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Second incident of same circumstances within four month period. Unknown cause. No patient injury.


Device:
Type: Device, Monitoring, Intracranial Pressure
Manufacturer: CODMAN & SHURTLEFF, INC.
Brand: Codman Microsensor Ventricular Catheter Kit Sensor With Icp Sensor
Model#: 82-8653

Problem:
Our facility is concerned that we were not informed of the MRI incompatibility of the Codman Microsensor ICP transducer. Approximately 6 years ago, it was believed the device was safe for use in the MRI environment. Three years later, there was a memo sent from Codman Regulatory Affairs stating that the compatibility of the device with MRI was not determined by FDA. Most recently, we have noticed the device package insert states MRI compatibility not determined. We have been imaging patients with Codman Microsensor ICP transducer without incident. Approximately 10 patients per year.


Device:
Type: Stimulator, Spinal-cord, Totally Implanted For Pain Relief
Manufacturer: Medtronic Neuromodulation
Brand: Restore Ultra
Model#: 37712

Problem:
Device was explanted. Approximately 3 weeks prior to explantation, patient had an MRI at a medical facility (other than ours). After the MRI, the device stopped working.



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Special Note: The lollipop icon distinguishes highlighted reports that describe medical device events involving neonatal or pediatric patients, or those events involving a medical device that is indicated for use in neonatal and pediatric patient populations. FDA defines pediatric patients as less than 21 years of age.

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Medical Device Problem Summaries

Summary of MedSun Reports Describing Problem With Patient AC-Powered Lifts

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An AC-powered lift is an electrically powered device either fixed or mobile, used to lift and transport patients in the horizontal or other required position from one place to another, as from a bed to a bath. The device includes straps and slings to support the patient (21 C.F.R. pt 880.5500).

Over the past 2 years, MedSun has received 7 adverse event reports with ac-powered patient lift devices manufactured by ArjoHuntleigh, Waverly Glen Systems, Joerns Healthcare, and Liko. The reports were submitted by 7 hospitals between January 2009 and January 2011.

The reported device problems were (each problem listed was reported once):

• Component removal and patient falling on top of the mounting bar
• Sling fraying
• Lift support post sliding out of position
• Sling strap cuff too long and interfering with sensor
• Sling metal ring sliding out of position
• Lift not able to go to lower position
• Report of lift dropping too fast

None of the reports involved patient death. The patient injuries listed below were reported in 2 of 7 reports (each injury listed was reported once):

• Significant injury to the abdomen requiring surgical intervention
• Minor bruises on the face

Of the reports that listed patient age, one report had a patient age listed as less than 21 years and 5 had patient age listed as greater than 21 years. Of the reports that listed patient gender, a total of 3 reports involved female patients and a total of 3 reports involved male patients. Of the reports that listed patient weight, 3 reports involved obese or morbid patients.

These MedSun reports listed above, in addition to manufacturer, healthcare, and voluntary reports contributed to FDA awareness of the device problems.

The following recall is associated with ac-powered patient lifts since 2009. The MedSun reported events may or may not be involved in the recall listed.

Recall Number: Z-1990-2009

Date Posted: August 31, 2009

Product: BHM Combi Sling, 100% Polyester Shell/100% Polyester Strap; soft polyester net fabric sling for ceiling and floor patient lifts; BHM, Magog, Canada, made in China. Part 626002: Combi Deluxe - Medium, capacity 68-113 kg, 150-250 lbs; Part
626002M: Combi Mesh Deluxe - Medium, capacity 68-113 kg, 150-250 lbs; Part
626002C Combi Sling Deluxe Small, capacity 20-68 kg, 45-150 lbs; Part 626002C-M
Combi Sling Mesh Deluxe Small, capacity 20-68 kg, 45-150 lbs; Part 626003: Combi
Deluxe - Large, capacity 113-272 kg, 250-600 lbs; Part 626003M: Combi Mesh
Deluxe - Large, capacity 113-272 kg, 250-600 lbs; and Part 626003X: Combi
Oversize Heavy Duty, capacity 113-272 kg, 250-600 lbs. Between 2004 and 2006,
the Combi Slings were labeled as BHM Medical Inc. (800) 868-0441, 100% Polyester
Shell/100% Nylon Strap, made in Canada. Prior to 2004, the slings were labeled
Medi-Man, 100% Polyester Shell, Rehabilitation Products Inc., Mississauga,
Ontario, Canada L5T 1X7, made in Canada. The accessory is intended to be used
with patient lift for the transfer of patient in hospitals, nursing homes, or other health care facilities by trained caregivers.

Code Information: All lots of BHM/Medi-man Combi Slings released prior to 2/1/09: Part Numbers 626002, 626002M, Part 626002C, Part 626002C-M, Part 626003, Part 626003M and Part 626003X.

Recalling Firm/Manufacturer:B.H.M. Medical, Inc. 2001 Tanguay Street Mago, QC

Action: Arjo sent "Urgent Device Recall Customer Notification" cover letters dated April 15, 2009 to the end user accounts who received the affected BHM/Medi-Man Combi Slings, to the attention of the Administrator/Risk Manager, advising them of the potential for possible stitching failure that could lead to a hazardous situation. Enclosed with the letter was a copy of the BHM Medical Field Safety Notice, FSN 10/2009/ca, dated April 3, 2009 which was sent to their BHM customers in the U.S. on April 7, 2009. The FSN identified the part numbers of the BHM/Medi-Man Combi Slings, described the potential health hazard, and listed the actions to take. The accounts were instructed to inspect and assess their slings' suitability for use per the Slings Maintenance Instructions. If the sling is showing this kind of breakage, the account was instructed to remove it from use and discard it immediately. If the inspection reveals no deterioration of the stitching, the sling is safe to use. The accounts were requested to complete and return the enclosed FSN receipt form within 10 days, acknowledging the receipt and understanding of the letter, and indicating the number of slings in use prior to inspection, the number of slings in use after the inspection, and the number of slings rejected. The accounts will be contacted for the replacement of their eligible old slings (in use up to two years).

Distribution: Nationwide

Recall Information online available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81859


The following table lists MedSun reports that are described in the device problem summary above.

Note: The reports have been edited for clarity.

Problems Reported With Patient AC-Powered Lifts
Device (Manufacturer, Brand Name)Device Identifiers (Model Number, Catalog Number) Event Description
ArjoHuntleigh, Sara Plus Advanced Standing and Raising aid
NA, NA A patient was admitted for a planned orthopedic surgery to apply an external fixator to their right lower extremity. Post-surgery, the patient was assisted up into a wheelchair by staff. The pateint later indicated she was ready to go back to bed and staff began to assist with the transfer. During that transfer the patient lost her gait so a staff member grabbed the "Sit and Stand" to help with the transfer procedure. Once staff set up the lift, it was noted the shin guard portion of the foot plate was in the way of the external fixator on her right leg. Staff then removed the shin guard to facilitate the transfer. The patient was unable to stand and perform the transfer and was guided to the floor. Once on the floor, the patient complained of pain and staff noted that she had fallen on a portion of the lift equipment. The patient was moved off the equipment and assisted back to bed with a full lift. A physician quickly came to evaluate the pateint and it was determined the patient sustained a significant injury to her abdomen, one requiring surgical intervention for the treatment of her wound. It was determined the patient fell on top of the bar that would hold the shin guard, causing significant injury.
Waverly Glen Systems, NA C-625, NA From a sister hospital it was learned that a patient weighing approximately 620 pounds was lifted from the bed to the chair. For this transfer, two lifts were used in tandem. As the patient was lifted to the chair, a piece of the bottom lift fell down, while the black lift belt began to fray in one place. Maintenance was made aware and they came to repair the piece that fell. During this repair, they said that when the patient is discharged they would repair the frayed belt but to go ahead and use it until then. As the patient was being transferred back to bed the belt began to fray in two additional places. There was no patient injury in this lift transfer, only potential for harm.
Joerns Healthcare, Voyager Easy Track
Model: 98000, NA Patient was being transferred with voyager lift from his bed to an electric wheel chair. While positioned directly above the chair, one of the supports of the lift slid out of position causing the patient to fall on to the floor. At the time of this event, the patient was a quadriplegic and wearing a halo brace. This device is a portable ceiling type lift. This lift runs across a guide rail that is mounted to two posts that are wedged from the floor to the ceiling on either side of the bed. During the use of the device in this event, the lift was set up in a patient's room. The posts were wedged up against a false ceiling, or hung ceiling tile system that is only supported by an aluminum infrastructure.
ArjoHuntleigh, MaxiSky 600 Patient Lift
Model: LD10211, NA
This report is intended to communicate a manufacturing issue that has not impacted a particular patient yet. Our institution has about 70 Arjo lifts in service and this report is intended to illustrate the problematic interaction between the lift device and the new replacement patient lifting strap. Currently, the replacement lifting straps have a longer sewing cuff than the originals. After routine replacement of the strap; the lift was tested. During this test, it was cycled from the fully retracted to the fully deployed state. While fully deployed, or all the way out, it was discovered that the longer sewing cuff interfered with the sensor that measures when the strap is fully retracted. The lift would not retract because the sensor indicated it already was fully retracted nor would it deploy further as it was at the end of the strap. The result is that the patient stretcher was suspended in mid-air and it would no longer respond to hand control input. When the lift was occupied by a patient, the patient would have to be manually lifted out, and placed on the bed. This poses a risk for both staff and patients. We are emailing companion video to MedSun illustrating the problem. The sewing cuff was too long and caused the lift to 'freeze' in the fully deployed position.
Liko, Viking
Viking M, 2040005 A patient was being lifted out of bed to reclining chair using a patient lift device. Mid-transfer one of the metal rings popped off and one of the lower pad loops came out of the device. The patient started to slide out of the pad, was caught, and then transferred to the chair safely without incident.
ArjoHuntleigh, :Maximove
KMBB4ELU2FUS, NA
Patient was being transferred to the commode by PT/OT [Physical Therapy/Occupational Therapy]. Once the patient was lifted in the air; the Maximove would not lower from the remote, or from the controls on the lift. Batteries were exchanged and that did not fix problem. The other lift was brought in as a back up. The lift was tried again and it worked. Staff had forgotten about the emergency release.
Joerns Healthcare. Hoyer
HML 400, NA
OT/PT [Physical Therapy/Occupational Therapy] were attempting to lift a patient with a manual Hoyer lift. During the lift, the staff dialed the button to lower the patient slightly. The Hoyer lift lowered the patient to a point just above the floor; yet not touching. Three staff were assisting in the lift procedure, and a fourth came to assist and support the patient. The patient was not injured but was startled. Staff offered reassurance and comfort to the patient, as did her mother.

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Updated April 1, 2011

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