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U.S. Department of Health and Human Services

MedSun: Newsletter #55, December 2010

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Newsletter #55, December 2010

Articles

HiRes 90K Cochlear Implant Device: Recall - Malfunction

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FDA MedWatch Safety Alert

Advanced Bionics (AB) announced that it will voluntarily recall its HiRes 90K cochlear implant device and is retrieving all unimplanted devices in distribution. This action is being taken in response to two confirmed instances where the product experienced a malfunction requiring explantation. These recipients experienced severe pain, overly loud sounds and/or shocking sensations at 8-10 days after initial activation of their device.

Additional Information:

FDA MedWatch Safety Alert. HiRes 90K Cochlear Implant Device: Recall – Malfunction. November 27, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm235009.htm

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Micromedics, Inc. Surgical Sealant Dispensers, Nasal Septal Buttons, and Otological Ventilation Tubes: Class 1 Recall - Weak or Open Seals

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FDA MedWatch Safety Alert

These medical products are contained in sterile pouches that have weak or open seals. These products could become or have been contaminated due to compromise in sterility. This can cause serious adverse health consequences and/or death.

Additional Information:

FDA MedWatch Safety Alert. Micromedics, Inc. Surgical Sealant Dispensers, Nasal Septal Buttons, and Otological Ventilation Tubes: Class 1 Recall-Weak or Open Seals. November 23, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm234602.htm

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Needleless Pre-filled Glass Syringes: Stakeholder Advisory - Compatibility Problems with Needleless Intravenous Access Systems

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FDA MedWatch Safety Alert

FDA is notifying healthcare professionals, especially those working in emergency and critical care settings, of reports of compatibility problems when certain needleless pre-filled glass syringes are used with some needleless intravenous (IV) access systems. These syringes may malfunction, break, or become clogged during the process of attempting to connect to needleless IV access systems. Most of the reports have been related to pre-filled needleless glass syringes that contain adenosine, often when attempting to connect to some pin activated needleless IV access systems. Healthcare professionals, risk managers, and staff who purchase, stock, or administer emergency crash cart medications, operating room medications, emergency drug boxes, or types of emergency drug caches should be alerted to this incompatibility problem and potential for damage or blockage of the IV line and delay in administering the medication. Healthcare organizations currently using glass prefilled syringes should consider stocking adenosine supplied in vials or pre-filled plastic syringes as a back up measure.

Additional Information:

FDA MedWatch Safety Alert. Needleless Pre-filled Glass Syringes: Stakeholder Advisory - Compatibility Problems with Needleless Intravenous Access Systems. November 17, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm234219.htm

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Sigma Spectrum Infusion Pump Model 35700: Class 1 Recall: Risk of Over-Infusion

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FDA MedWatch Safety Alert

Affected units may fail suddenly, causing inaccurate flow conditions during use, ranging from back flow to over-infusion, including free flow. The pump does not issue an alarm when this occurs. These conditions could result in serious injury or death. Sigma has instructed healthcare facilities to verify whether the serial numbers for their infusion pumps fall within the range of pumps being recalled and is requiring the return of the recalled devices. Sigma has instructed users to not use the infusion pumps on patient populations, including neonatal patients, where inaccurate flow, ranging from back flow to over-infusion, including free flow, could result in serious adverse health consequences or death.

Additional Information:

FDA MedWatch Safety Alert. Sigma Spectrum Infusion Pump Model 35700: Class 1 Recall: Risk of Over-Infusion. November 12, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm233747.htm

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Triton Pole Mount Infusion Pump by WalkMed: Recall - Potential Door Open Alarm Problem

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FDA MedWatch Safety Alert

If the pump door is not closed and latched per the instructions for use located on the side of the pump and in the operator manual, the pump door open alarm may not alert the user to this condition. It is then possible for the pump mechanism not to be engaged and a gravity feed flow condition to exist if the pump operator has not checked tube set for flow prior to starting the pump. This could result in over infusion of medication. Consumers who have Triton Pole Mount Infusion Pumps which are being recalled should return the pump to the manufacturer.

Additional Information:

FDA MedWatch Safety Alert. Triton Pole Mount Infusion Pump by WalkMed: Recall - Potential Door Open Alarm Problem. November 8, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm233014.htm

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Hospira Symbiq One-Channel and Two-Channel Infusers: Class I Recall - Motor Encoder Failures

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FDA MedWatch Safety Alert

FDA and Hospira notified healthcare professionals of a Class 1 recall of these infusion pump products due to motor encoder failures in the pumping mechanism that causes the infuser to cease operation. Delay or interruption of therapy may result in serious injury or death. Until Hospira can upgrade all Symbiq pumping mechanisms, corrected loaner pumps will be provided at no cost to customers for critical care areas. Until loaner or corrected pumps are in place in critical care areas, Hospira urges customers to consider an alternate method to administer therapy.

Additional Information:

FDA MedWatch Safety Alert. Hospira Symbiq One-Channel and Two-Channel Infusers: Class I Recall - Motor Encoder Failures. November 4, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm232568.htm

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Reduce and Report Enteral Feeding Tube Misconnections

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FDA Medical Device Safety

Enteral feeding tubes that are mistakenly connected to other applications may result in patient death or injury, as is widely known within the healthcare community. But in the last four years, only a few of these adverse events were reported to the FDA. Misconnections of enteral devices may be underreported because connecting feeding tubes to the wrong tubing, such as an I.V. or dialysis catheter, is often attributed to human error rather than device failure. This potential underreporting causes concern because the risk of enteral feeding tube misconnections could be further reduced by incorporating human factors assessment into device design. For these reasons, all adverse events and “near misses” should be reported to the FDA, whether they’re considered device or human error.

Additional Information:

FDA Medical Device Safety. Reduce and Report Enteral Feeding Tube Misconnections. November 19, 2010.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm234440.htm

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Safety Investigation of CT Brain Perfusion Scans - Update

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FDA MedWatch Safety Alert

The reported cases of radiation overdose involved scanners manufactured by GE Healthcare and Toshiba America Medical Systems. FDA inspections of the companies found there were no violations of FDA laws and regulations. The FDA evaluated the manufacturers' specifications for multi-slice CT scanners and found that when these scanners were used according to the manufacturers’ specifications, they did not result in overexposure. Further, the FDA found no evidence that the manufacturers were involved in modifying any of the hospitals’ scanning protocols so as to cause the overexposures. The FDA is working with manufacturers of CT scanners to improve their instructions and training programs for this complex equipment, and to provide software safety checks that would prevent unreasonably high radiation doses from being delivered unintentionally.

Additional Information:

FDA MedWatch Safety Alert. Safety Investigation of CT Brain Perfusion Scans – Update. November 9, 2010.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm185898.htm

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LabNet

10 Point Yearly Safety Checklist

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Lab Manager Magazine

Safety checklists in the lab are a work in progress, but labs should be committed to updating a plan to account for new hazards as the lab evolves. A yearly safety checklist, or however often the lab conducts a full safety audit should be reviewed and updated as well. The article provides a sample checklist.

Additional Information:

Lab Manager Magazine. 10 Point Yearly Safety Checklist. September 16, 2010.
http://www.labmanager.com/stips.asp?ID=142

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Proper Eye Protection

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Lab Manager Magazine

Approximately 2,000 eye injuries occur on the job every day, resulting in lost time away from work. And three out of five eye injuries are due to employees not wearing any eye protection at all. Even minor eye injuries can cause long-term vision problems and suffering. Research laboratories have their own unique eye hazards, and eye protection should be worn all the time, even by visitors. It is also not a question of when eye protection is needed, but the correct type of safety eyewear; many of the 2,000 injuries per day that require medical attention are caused by wearing the wrong type of eyewear. This article provides tips on how to prevent eye injuries.

Additional Information:

Lab Manager Magazine. Proper Eye Protection. October 7, 2010.
http://www.labmanager.com/stips.asp?ID=145

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Thioglycollate Culture Media and Tissue Samples: MedSun Small Sample Survey Summary

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MedSun Newsletter

This MedSun Small Sample Survey summary originally appeared in November's MedSun newsletter. The LabNet team would like to reiterate its importance since the survey was conducted to better understand laboratory professionals' experiences with the use of thioglycollate media with gram stain procedures.

Additional Information:

MedSun Newsletter. Thioglycollate Culture Media and Tissue Samples: MedSun Small Sample Survey Summary.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/news/action.cfm

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HeartNet

External Defibrillator Improvement Initiative

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FDA Medical Device Safety

FDA is beginning an initiative to foster the development of safer and more effective external defibrillators through improved design and manufacturing practices, and urge industry to address current practices for identifying, reporting, and acting on the device complaints. FDA will host a public workshop on December 15 - 16, 2010, with multiple stakeholders to facilitate the development of next-generation defibrillators, enhance surveillance of defibrillators in community settings, and improve the rapid delivery of treatment for sudden cardiac arrest patients.

Additional Information:

FDA Medical Device Safety. External Defibrillator Improvement Initiative. November 15, 2010.
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/CardiovascularDevices/ExternalDefibrillators/ucm232302.htm

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HomeNet

Home Hemodialysis Systems: MedSun Small Sample Survey Summary

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MedSun Newsletter

This MedSun Small Sample Survey summary originally appeared in November's MedSun newsletter. The HomeNet team would like to reiterate its importance for home care providers and recipients because it summarizes users' experiences with Home Hemodialysis (HHD) systems. The information learned from this survey is important since hemodialysis systems are often used in an out-patient clinic as well as in the patient's home environment.

Additional Information:

MedSun Newsletter. Home Hemodialysis Systems: MedSun Small Sample Survey Summary.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/news/newsletter.cfm?news=54#17

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KidNet

Adverse Events Associated with Neonatal Laparoscopy: Are They Truly Rare Events or the Tip of the Iceberg?

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Anesthesia Patient Safety Foundation

As the indications for laparoscopic procedures expand, often without adequate scientific studies to assess the risks and benefits, anesthesia professionals may be among the first to recognize patient safety issues. Recent reports of catastrophic events associated with neonatal laparoscopy may suggest that its popularity is unfounded for minor procedures. Although studies in the surgical literature report statistically significant reductions in hospital stay and time to enteral feeds for laparoscopic compared with open pyloromyotomy, these results are measured in hours and may be clinically and financially unimportant.

Additional Information:

Anethesia Patient Safety Foundation. Adverse Events Associated with Neonatal Laparoscopy: Are They Truly Rare Events or the Tip of the Iceberg? Summer 2010.

http://www.apsf.org/newsletters/pdf/summer_2010.pdf

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Webcast: PICC and Umbilical Catheter Safety in Neonatal Patients

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MedSun Educational Materials

Please visit the Educational Materials page for a newly posted webcast entitled, PICC and Umbilical Catheter Safety in Neonatal Patients sponsored by KidNet and presented in October of 2010. The webcast discusses medical device safety during insertion and care of peripherally inserted central catheters (PICC) and umbilical catheters in neonatal patients. Case studies are also included in this webcast presentation.

Presentation slides and transcripts are available for this webcast. A direct link to this program may be found under Additional Information below.

Additional Information:

PICC and Umbilical Catheter Safety in Neonatal Patients. October 28, 2010. MedSun Educational Materials.
http://www.fda.gov/MedicalDevices/Safety/MedSunMedicalProductSafetyNetwork/ucm234684.htm

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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 2010. 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: Apparatus, Autotransfusion
Manufacturer: Fresenius Medical Care North America
Brand: Continuous Autotransfusion System
*Same device information for all 4 machines

Problem:
C.A.T.S. [Continuous Autologous Transfer System] is a hemo cell saving device used in surgery. Staff started noticing that the scavenged blood (re-infusible blood) was at a much lower than expected volume. Example: scavenge 2700mL but could only return 300mL. Staff also noticed that the blood in the waste bag looked darker and thicker than normal. No changes had been made in accessory equipment such as tubing or fluids. We have 4 machines and problem was not confined to any one of them. The surgical procedure being done didn't seem to affect the reduced volumes. The situation caused increased use of banked blood for multiple patients.
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Health Professional's Impression
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Increased the amount of banked blood patients required due to lower usable volume of scavenged autologus blood.
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Manufacturer response for Autologus blood scavenging device, C.A.T.S.
======================
Terumo provides customer support - third party servicer. They have come onsite and tested the devices. They cannot determine cause. Terumo states the 4 units should be replaced and are making such arrangements.


Device:
Type: Tube, Tracheostomy (W/wo Connector)
Manufacturer: Spectrum Surgical Supplies
Brand: Jackson Improved
Model#: 34-915

Problem:
Patient had Size 5 Jackson metal tracheostomy with wheel-style inner cannula placed. Respiratory Care called to bedside for trach site care the day after placement of the trach. Unable to remove inner cannula for cleaning - it appeared that the inner cannula was fused in place. Could not remove inner cannula without injury to patient. Clinical Engineering notified of problem--4th instance of this problem at this institution in this year. Dr from SICU [Surgical Intensive Care Unit] notified immediately for trach tube change at bedside. Patient was unharmed, but had delayed discharge due to trach tube needing to be changed out. Clinical Engineering believes there may be a design issue with this "Jackson Improved" style of trach tube, where secretions can seep between the inner and outer cannula and dry up, which makes it difficult to remove the inner cannula.
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Manufacturer response for Jackson Tracheostomy Tube, Jackson Improved
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No response yet.


Device:
Type: Ventilator, Continuous, Facility Use
Manufacturer: Maquet, Inc
Brand: Servo-i
Model#: 6487800
Other #: Compressor-Model #6481779

Problem:
Brand new Servo-i ventilator failed on a patient. The ventilator compressor began overheating and alarming "high temp". Ventilator began producing a "burning smell." The ventilator was immediately removed and changed out with another to prevent patient injury.

It was determined that the burning smell was probably due to the circuit blowing out and not due to the compressor actually overheating and that there were no burn marks on the compressor.
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Health Professional's Impression
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Not sure at this point. Equipment will be serviced by vendor and will not know until after this occurs.
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Manufacturer response for Ventilator, Maquet Servo I Ventilator
======================
Sending person to hospital to assess equipment.


CARDIOVASCULAR

Device:
Type: External, Defibrillator
Manufacturer: Philips Medical Systems
Brand: Heartstart Mrx
Model#: M3535A

Problem:
An ICU patient went into V-fib while eating breakfast. CPR initiated and crash cart brought to room. Unable to defibrillate the patient. An "X" appeared in a window in the right upper part of the screen on an MRx defibrillator. The nurse manager (NM) attempted to reset but was unable. A second HeartStart was immediately brought to the room. The patient was connected and was defibrillated once with a return of rhythm. A newly-hired ICU patient care technician (PCT) had performed the daily check on the defibrillator earlier in the day and it passed (test strips confirm this). Although the NM instructed this PCT on checking HeartStart defibrillators during her orientation by demonstration and return demonstration of discharging the pads and then the paddles, the PCT stated that she was also oriented by another ICU PCT to check the heart stations by performing an "operational check" on the HeartStart. The day of the event; the PCT performed an operational check on HeartStart MRx and all areas passed. She then did another check seven minutes later on the same HeartStart defibrillator and all areas passed, but the pacer test failed. This created the "X" in the window. The PCT did not notify anyone of the "X" and when the HeartStart was brought to the room 20 minutes later for the code blue, it was discovered. NM interviewed the PCT and had her demonstrate how she performs her daily HeartStart checks on another HeartStart and the same area "failed" and created the "X" in the window. NM was unable to reset and biomed tech asked to come to ICU and evaluate. Tech immediately came to the ICU and identified the problem; the PCT was performing the daily HeartStart check incorrectly using the "operational check" method. She was performing 2 operational checks on both pads and hands-free cable which created the failure with the pacer test.

Biomed took the MRx HeartStart defibrillator used in the code blue to their shop for testing. NM educated this PCT and will re-educate all PCT's and RNs in the ICU that daily HeartStart checks should be done using the "discharge" method and that both pads and paddles are to be checked. No operational checks are to be done by nursing. Biomed will perform the "operational" checks on all heart stations as they always have been. The patient is currently vented and sedated.

No further follow up on HeartStart required from ICU perspective at this time.

Health Professional's Impression: Confusion of proper operation.


Device:
Type: Monitor System, Physiological, Central
Manufacturer: Philips Medical Systems
Brand: Intellivue
Model#: M3155

Problem:
Shortly after upgrading all Patient Information Centers (PIC) of a Philips IntelliVue system seven months ago, the PIC in ICU would intermittently lose the audible portion of alarms (become muted). This usually occurred during the midnight shift. During those times when alarm audio became muted, the clinical staff would enable bedside audible alarms. The on-call Biomed tech would respond to the problem, confirm the audio volume had been set (changed) to "mute" and re-boot the PIC to restore alarm audio. This situation continued intermittently for five months.
Manufacturer response for Monitor System, Physiologic, Central, IntelliVue: Visits by Field Service Engineer. Error and event logs forwarded to factory for analysis.


Device:
Type: Monitor System, Telemetry Central
Manufacturer: Philips Healthcare
Brand: Intellivue
Cat #: M3155

Problem:
On the morning of the event, a Central Monitoring Unit (CMU) tech was reordering the display of telemetry patients on the same care unit. The CMU tech inadvertently switched two patient room numbers, placing patient 'A' in room 236 and patient 'B' in room 235 (in actuality, the patients were in opposite rooms). The CMU tech was changing patient telemetry sectors when she swapped the patients between sectors 5 and 6. Later in the morning, the rhythm for patient 'A' changed as he began to exhibit significant cardiac pauses. Thus, the nursing staff quickly responded to patient 'B' in room 235. After noting that the patient name was different from the telemetry monitor display, the clinical staff raced to room 236 and attended to patient 'A', thereby averting treatment to a wrong patient while another patient was unattended for a potentially life-threatening event. Shortly after stabilizing patient 'A', a nurse noticed that the telemetry patient names did not correspond correctly for the room numbers. CMU was notified of the situation and the error was corrected. Patient 'A' was transferred to CVICU. Verified that a CMU tech did indeed transpose two patient assignments. Lacking an ADT interface (called an HAI interface by Philips); the current manual data entry method does not have a safeguard to ensure data accuracy. Hospital has budgeted for HAI interface and implemented a process of verifying patient and room locations in the Philips central system.

Health Professional's Impression: Product allowed for incorrect correlation of room numbers and patient names.


Device:
Type: Monitor, Physiological Central Station
Manufacturer: Philips Medical Systems
Brand: Intellevue Patient Information Center

Problem:
During monitoring of telemetry patients in our Cardiac Monitoring Unit, the central station display froze and would not allow the keyboard or the mouse control on the central station application. Trouble shooting the system determined that when the user switched from left central display to the right central display via an electronic Keyboard/Video/Mouse (KVM) switch, one of the monitors would lock up preventing the monitoring tech from controlling alarms and display operations. The keyboard and mouse on the M3151 Patient Information Center (PIC) units are of the PS2 connection type. Biomedical also determined that the Central Station kb/mouse control would freeze when devices were disconnected directly from the central station PC. Biomedical confirmed that when KVM switch was activated the new display selected would not have controls. Biomedical then connected the keyboard and mouse directly to the M3151 and rebooted the computer and application to get the mouse and keyboard to operate. Biomedical determined that this is the same action that all PS2 keyboards and mice exhibit when disconnected from their PS2 ports. The same was happening when the user switched the KVM switch. Occasionally the computer would lock up and not allow the user control of the PC based central station.

Biomedical has requested that Philips Medical convert the PS2 style connector to the newer plug and play USB keyboard and mice but the company stated that they had to use what was designed for the product. Biomedical could not locate any service documentation or company information on the Philips web site for the KVM switch that was supplied from Philips.


Device 1:
Type: Monitor, Physiological, Module
Manufacturer: SpaceLabs Heathcare, Inc.
Brand: Ultraview, Command Module
Model#: 91496
Other #: Software version: v2.02.04 with options 1cgnr3

Device 2:
Type: Monitor, Physiological
Manufacturer: SpaceLabs Heathcare, Inc.
Brand: Ultraview Sl
Model#: 91387
Other #: Option: 21808

Problem:
Patient found by nurse in asystole, and monitor did not sound alarm. Code called, unable to resuscitate patient. Post event print out from monitor showed that prior to event, monitor showed patient respirations with artifact. The monitor showed flat line, but obviously the patient was not asystole, because patient breathing and moving. During Code, monitor showed CPR compressions, and post code the monitor alarmed.

Health Professional's Impression: Because monitor did not alarm, Code may have been delayed for patient in asystole.


CLINICAL CHEMISTRY

Device:
Type: Vacuette 2ml Green Tubes
Manufacturer: Greiner
Brand: Vacuette
Lot #: 2200266
Cat #: 454237
Other #: B061006

Problem:
After receiving approximately eight contaminated blood samples, lab personnel tested tubes and determined they were contaminated. It appears that tubes contained wrong anticoagulant. Approximately 500 tubes were internally recalled for return to vendor. No patients were injured as result of this.
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Health Professional's Impression
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contaminated lot
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Manufacturer response for vacuette 2ml Green tubes, vacuette
======================
Have replaced product. Unknown if they have done internal investigation of product.


GASTROENTEROLOGY & UROLOGY

Device:
Type: Light Source
Manufacturer: Stryker Endoscopy
Brand: Stryker
Model#: X8000

Problem:
Light source went from automatic to full spontaneously. Setting for light source was on standby. The camera setting was on Laparoscopy specialty. Light source was plugged in, placed on standby and a couple of minutes later noted to be on.
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Manufacturer response for Light source, X8000
======================
Asked Stryker to come and evaluate device.


GENERAL & PLASTIC SURGERY

Device:
Type: Instrument, Surgical
Manufacturer: Medtronic Xomed
Brand: Incrementing Probe With Standard Prass Tip
Lot #: 67770800
Cat #: 8225825E

Problem:
The incrementing probe with standard prass tip lot# 6777800 does not seat in to the Nim machine holder to work. If you line the arrows up the instrument does not seat in to the holder. Informed RN and pulled these lot numbers from machine number. Opened a new one with lot# 67770400. It seated just fine.


Device:
Type: Needle Holder
Manufacturer: Teleflex Medical
Brand: Bulldog
Model#: 511136

Problem:
During open heart procedure (CABG), the surgeon placed the first stitch onto the graft using the needle holder. When he went to pick up the needle for the next stitich, the needle holder would not grasp the needle. Upon closer examination, it was noted that a small piece of metal was missing from the grasping part of the needle holder. Exhaustive search of the patient's surgical area was done including: manual, radiology, and use of a sterile magnet across the field. The metal piece could not be located. Disclosure was made to patient/family.

There must have been a small fracture in the metal of the needle holder that was not detectable by the naked eye during routine cleaning or by the routine PM's we have done on the equipment.


Device:
Type: Stapler, Surgical
Manufacturer: Ethicon Endo Surgery, Inc.
Brand: Endoscopic Curved Intraluminal Stapler
Model#: ECS 29
Lot #: G4RY8F
Cat #: ECS 29
Other #: 29mm

Problem:
OR Tech reports patient in OR undergoing left hemicolectomy and sigmoidectomy using the EEA Endopath ILS endoscopic curved intraluminal stapler. When the surgeon attempted to close the handle to fire the stapler the black plastic handle cover fell off of the handle. The surgeon was able to complete the case as the stapler remained functional and there was no patient harm. Unsure why plastic cover handle fell off as the bottom one remained intact. Broken handle was accidentally disposed of in the trash but stapler itself is available for evaluation purposes. After breakage surgeon did check the patient's colon reanastomosis to make sure the stapler had worked appropriately and pulled the excess "donut" pieces out and they were intact and complete. We believe the black plastic handle is for appearance and comfort only as the stainless steel handle beneath it is quite substantial.
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Health Professional's Impression
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Handle broke


GENERAL HOSPITAL

Device:
Type: Broviac Catheter
Manufacturer: Bard Medical Division
Brand: Broviac Catheter
Lot #: REUA0022

Problem:
Arrived on unit to assess new broviac catheter placed and do teaching with parent. The bedside nurse indicated catheter was leaking and that the patient's chest was swollen subsequent to attempted infusion. The patient was required to return to OR for placement of broviac catheter. There is a small hole in the line. The physician does not believe the hole was caused during the attempt to access to the line, but cause remains unknown.


Device:
Type: Catheter, Picc, Introducer
Manufacturer: Becton Dickinson and Company
Brand: Bd L-cath Picc And Bd Splittable Needle Introducer
Lot #: 9334052
Other #: Reference Number: 384061

Problem:
The introducer needle was inserted and able to insert PICC to hub. The introducer needle was withdrawn, but would not peel away. When attempted to peel, the needle broke off one side, but would not peel away. In attempts to peel away the needle, the catheter was punctured necessitating removal of the catheter and an additional venipuncture for the patient.


Device:
Type: Catheter, Port, Implanted
Manufacturer: Angiodynamics Inc.
Model#: MP-P5SAT
Lot #: 503882


Problem:
Patient scheduled to have a mediport dye study for assessment of mediport. This study was being completed due to the fact that the parents, homecare, and outside hospital were not having success with blood returns even with interventions such as altepase. After mediport accessed and an image was taken, it was noted by MD that the catheter was detached from the mediport. The tubing and port were removed and was replaced with new line.


Device:
Type: Custom Breast Support
Manufacturer: VanArsdale Innovative Products Inc.
Brand: Vip
Model#: VIP-CBS-11
Other #: Hospital PO number 1C1375606

Problem:
Patient got a burn below left breast from custom breast support remaining too hot. It is believed that the sponge frame contained too much hot water."
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Health Professional's Impression
======================
Hot water is necessary to form the breast support. The hot water may not have been entirely squeezed out of sponge frame.


Device:
Type: Incubator, Infant
Manufacturer: General Electric Healthcare
Brand: Giraffe Incubator

Lollipop Icon

Problem:
A loud noise and sparks were seen coming from the electrical outlet behind an isolette in the NICU. Upon inspection, there was a frayed area that had made a hole through the cord connected to the isolette plug.

BioMed contacted the manufacturer of the isolette. The manufacturer had changed the way they wrap the cord. There will be a design change made for future models.
Velcro straps were added to the cords of current isolettes.


Device 1:
Type: Infusion Pump Control Unit
Manufacturer: CareFusion 303, INC.
Brand: Alaris System
Model#: 8015

Device 2:
Type: Pca Pump Module
Manufacturer: CareFusion 303, INC.
Brand: Alaris
Model#: 8120

Problem:
An oncology patient was being infused morphine through the Alaris system PCA pump. The original volume to be infused was 30cc placed in a 35cc syringe. After aproximately 45 minutes from the syringe being hung, the nurse noticed the patient coming out of the bathroom with the pump alarming. It was noted that there was approximately 5cc left in the syringe.

Due to the pump's Guardrails dose error reduction software, the pump could not have been programmed to infuse at the rate needed to the empty the syringe in so short of a time. The pump's door and locking mechanism do not appear to have any damage.

When closing the door of the pump, there is a point where the door is hitting the door closed sensor and the pump is reading the door as closed (does not alarm, allows infusion), but the door latch is not securing the door. In this instance, the pump will infuse as normal and the door will appear secure. In fact, the door will stay closed if the pump is picked up and walked across the room. However, the door is not latched and only a little pressure is needed to open the door.

Two other PCA modules were tested. Both modules also had the same issue where the door could be closed and the pump read the door as closed, but it was not latched.
======================
Health Professional's Impression
======================
Patient had manipulated the pump in order to self medicate


Device:
Type: Infusion Pump, General Purpose
Manufacturer: Hospira Inc
Brand: Symbiq
Model#: 16026-04-83

Problem:
An ICU RN hung the initial 22:00 dose of Xigris IV piggyback per protocol, programmed IV pump and left room. Returned at 23:00 to check blood sugar and IVs; realized entire bag had infused. Rechecked Xigris rate and discovered the pump was programmed to infuse the 13.6ml rate as 13.6mcg. RN assessed patient, no bleeding found, no changes in skin tone, and neuro status. Notified ACL (attending clinician) and hospitalist. Hospitalist at bedside to assess patient. Call made to pharmacy for further instructions and ICU interventionist made aware. Post 24 hours from event, patient found to be unharmed. Complete blood count (CBC) drawn at 00:00 and 05:00, unchanged from previous. No changes in patient's condition and patient reported feeling good. Xigris held until next scheduled dose of 06:00.


Device:

Type: Phototherapy, Neonatal
Manufacturer: Datex Ohmeda/GE
Brand: Biliblanket Plus High Output
Other #: REF: 6600-0656-801

Lollipop Icon

Problem:
The patient was in a breastfeeding position when mother noticed one superficial linear abrasion along with two red linear marks on the right inner thigh. The abrasion appeared to be a scratch. Upon removing the paper covering on the tubing of the Omeda bili-blanket, it was noted by RN that the plastic cover of the Omeda phototherapy tubing was separated from the bili-blanket. A hole was noted on the outer covering and a firm piece of plastic was protruding. That bili-blanket unit was immediately replaced with an intact unit.
======================
Health Professional's Impression
======================
According to the biomedical technician, the integrity of the protective sheath on the proximal (patient-end) end of the tubing was compromised exposing a sharp protrusion (material not known/available). The exposed tip scratched the infant and caused minor injury.


Device:
Type: Picc Line
Manufacturer: Bard
Brand: Picc Single Lumen
Lot #: REUC1451
Cat #: 3174108

Problem:
During the insertion of the line into the right brachial vein, staff noted that the guide wire was not threading smoothly. The guide wire appeared to be stuck and once the stylet was removed, the guide wire remained in place. It appeared as though the product uncoiled allowing the guide wire to separate from the flexi-tip, which allowed the guide wire to remain in the patient's subcutaneous tissue. A surgery consult was obtained and the guide wire was successfully removed.

It appeared as though the product uncoiled, allowing the guide wire to remain in the patient's tissue.


Device:
Type: Smart Site Infusion Set
Manufacturer: CareFusion
Brand: Alaris
Other #: ref # 2420-0007

Problem:
Intralipid tubing found on floor beside patient bedside. Tubing disconnected spontaneously, staff did not state exactly where disconnected but looking at tubing looks like tubing disconnected from needle free valve port, needle free valve port not included in this tubing that was saved.


Device:
Type: Warmer, Infant Radiant
Manufacturer: GE Healthcare
Brand: Ohio Infant Warmer System
Model#: 4400

Lollipop Icon

Problem:
Infant placed in warmer with temp probe in appropriate place and well adhered. Setting changed to skin(servo) as per protocol. Warmer adjusted to temp of 35.6 C. Within 1/2 hr infant noted to be very red on entire back where exposed to radiant heat. Pt temperature on warmer read 35.6 C. Warmer was putting out full heat. Warmer turned off immediately, infant cooled with cool water and placed in isolette. Infant's color on back returned to normal within 30 minutes.
The temperature probe was retrieved by BioMed the next day to use for testing with the warmer and no problems were identified. They were unable to replicate any malfunctions with the system. No other means of temperature monitoring was used on this infant. The temperature probe was taken to the isolette with the infant and functioned correctly. Question whether an actual problem with the equipment or if the infant simply had hyper-reactive skin to the radiant heat. No problems developed after this incident with the infant.


NEUROLOGY

Device:
Type: Catheter, Thrombus Retriever
Manufacturer: PENUMBRA INC.
Brand: Penumbra
Model#: Reperfusion Catheter 032
Cat #: psc032

Problem:
The patient is a middle-aged woman with little medical history and apparently no medications previously, who presented to the emergency room last month with symptoms of acute CVA. She was evaluated emergently per the code stroke protocol and given t-PA for her symptoms suggestive of acute uncomplicated stroke. She was refractory to t-PA and taken for angiography and attempted aspiration of an MCA distribution clot the following day. Each time the clot was aspirated, the area rethrombosed, and ultimately, the procedure was abandoned. She went on to infarct that area of her brain and developed malignant cerebral edema requiring craniectomy procedure, also this day. The patient has had a stormy hospital course with issues, including inappropriate antidiuretic hormone secretion syndrome (SIADH), pleural effusion, hospital pneumonia, and what appears to be a state of coma with respiratory failure requiring full ventilator support. She remained on norepinephrine vasopressor to maintain a target mean arterial pressure for adequate perfusion of her brain until family chose to make the patient a DNR and have life support removed.

At pathologic exam, the pathologist noted that the patient appears to have material in the cerebral vessel. There has been recent literature suggesting that hydrophilic polymer emboli can result from diagnostic cerebral angiography (Modern Pathology, (2010)23: 921-930). The pathologist is questioning if the material in this patient's vessels was the result of polymer shedding from the catheters used during the cranial angio. (Several catheters and guidewires from a variety of manufacturers were also used).
======================
Health Professional's Impression
======================
There has been recent literature suggesting that hydrophilic polymer emboli can result from diagnostic cerebral angiography (Modern Pathology, (2010)23: 921-930). The pathologist is questioning if the material in this patient's vessels was the result of polymer shedding from the catheters used during the cranial angio.
======================
Manufacturer response for cranial reperfusion catheter, Penumbra
======================
The neurointerventionalist contacted the manufacturer after speaking with the pathologist regarding findings of material in the cranial vessels.


Device:
Type: Holder, Head, Neurosurgical (Skull Clamp)
Manufacturer: PRO MED INSTRUMENTS, Inc.
Brand: Doro
Other #: Doro MRI compatible Head Fixation Device

Problem:
Patient's head positioned in MRI neuro headrest (Doro Fixation Device) with pins. Immediately after positioning the head slipped and one of the pins caused a laceration adjacent to the pin site. The laceration was sutured and the patient's head repositioned for sub-occipital craniotomy.


OBSTETRICS/GYNECOLOGY

Device:
Type: Clamp, Circumcision
Manufacturer: Centurion Medical Products
Brand: Circlamp
Lot #: 2010042601

Lollipop Icon

Problem:
This involved a infant undergoing circumcision by OB/GYN. MD placed clamp, tightened it, and began procedure. About half way through circumcision the clamp slipped causing a penile laceration. A urologist was contacted and repaired the laceration with sutures.
======================
Health Professional's Impression
======================
The clamp slipped and caused a laceration which required sutures.


ORTHOPEDIC

Device:
Type: Prosthesis, Hip, Metal/polymer
Manufacturer: Stryker
Brand: Custom Device
Model#: SHELL ACETB TRDNT E OD54MM HMS

Problem:
Patient for right hip replacement Femoral head trials were performed sequentially until adequate soft tissue tension, range of motion, stability and leg length were visualized intraoperatively. Upon placement of a 5 trial head there was excellent stability in the range of motion. Upon routine dislocation however, physician was unable to locate the femoral head trial. Several attempts made to locate the head with C-Arm (fluoroscopy) guidance and the trial head could not successfully be retrieved. To be safe, given the neurovascular structures within and since the trial head had migrated, a decision to remove the trial implant with an additional incision was made and performed by two other surgeons who quickly and efficiently located and removed the trial head via separate incision using a retroperitoneal approach.

By design the trial head is to come off, the purpose of this report is to warn of this possibility and the potential migration of the device into the retro peritoneum as it did in this case.


PHYSICAL MEDICINE

Device:
Type: Medication Cart
Manufacturer: InterMetro Industries Corp.
Brand: Lionville Lock Alert Ii
Model#: 800 series

Problem:
The batteries are not able to charge due to power supply failure which causes the cart not to function. Patient care is adversely affected because medication can not be distributed to patients in a timely manner due to maintenance constantly being performed on medication carts.
======================
Manufacturer response for Medication Cart, Lock Alert II
======================
The manufacturer sent a replacement power supply and wiring harness.


Device:
Type: Nurse Call System
Manufacturer: RAULAND-BORG CORPORATION
Brand: Responder
Model#: Responder IV
Other #: FAMS - Fire Alarm Module

Problem:
Biomedical engineering responded to a call from a nursing unit in our new bed tower concerning intermittent "AUX" alarms. Investigation revealed two Rauland "FAMS" (fire alarm module)that were hot to the touch. Removal of the "FAMS" restored normal function. The "FAMS" had been "ty-rapped" together during installation. The vendor service rep replaced the devices and noticed that when the "ty-rap" was cut, the RJ-45 connector pins had pushed through the heat-shrink insulation on both "FAMS". These punctures resulted in an unintended electrical connection between the devices. Last week, one of our biomedical techs compared the construction of a faulty "FAM" to a NCSSPLIT4 from the same manufacturer and noticed that Rauland has incorporated a piece of puncture-resistant insulating material into the splitter insulation. The tech has speculated that perhaps someone at Rauland recognized the potential for problematic punctures in the production packaging of the splitter. However if that is true, it was not applied to the production of "FAMS". Our facility has 440 of these devices in use currently in our new bed tower.

See device image:
RJ-45 connector pins pushed through the heat-shrink insulation on the FAMS.



~~~~

Lollipop IconSpecial 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 Adverse Events With Cardiovascular Programmable Diagnostic Computers

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A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs (1).

Among general cardiovascular programmable diagnostic computers, there are several different device descriptions which further define this class of products:

Hemodynamic Catheterization System:
A hemodynamic monitoring system is used, “for monitoring vital signs before, during and after catheterization procedures.” It is intended to, “acquire, display, store, analyze and process vital signs and log all cath lab activity (2).”

Cardiovascular Mapping System:
A mapping system designed to, “acquire and analyze individual data points, and use this information to display 3D electroanatomical maps of the human heart in real-time (3).”

Cardiology Data Management System:
An ECG management system is used for, “importing ECG waveform data, reviewing and performing measurements, diagnosis and comparison of ECG procedures and storing the data for future review and management (4).”

Over the past 2 years, MedSun has received 10 adverse event reports associated with cardiovascular programmable diagnostic computer devices manufactured by Biosense Webster, G.E. Healthcare, McKesson Corporation, St. Jude Medical. Two MedSun reports contained multiple device problems. The reports were submitted by 8 hospitals between November 2008 and November 2010.

The reported device problems were:
•Software issues to include:
-Freeze - 1
-Failure to initialize - 1
-Display amplitude affective analysis algorithm - 1
-Unable to correlate catheter location properly - 1
-Loss of ECG display - 1
-Inability to archive images – 1

•Could not steer catheter - 1
•Could not identify the reference catheter - 1
•Defective amplifier - 1
•Defective DVD preventing software initialization - 1
•Interference causing image shift on display - 1

None of the reports involved a patient death. One report involved a minor injury to the patient and four reports were identified as potential for harm. Two MedSun reports resulted in multiple patient problems. The patient problems listed below were reported in 4 of these 10 reports:
•Patient converted to ventricular tachycardia requiring cardioversion - 2
•Patient received additional radiation/fluoroscopy – 2
•Increased procedure time – 2
•Redo of catheter procedure - 1

Of the reports that listed patient age, no reports had a patient age listed as less than 21 years and 8 had a patient age listed as greater than 21 years. Of the reports that listed patient gender, a total of 1 report involved a female patient and a total of 6 reports involved male patients.

FDA follow-up with the manufacturer resulted in multiple recalls. The following recall(s) are noted to be associated with the Cardiovascular Programmable Diagnostic Computer.


Recall 1:
Date Posted: July 09, 2010
Recall Number: Z-1974-2010
Product: Horizon Cardiology Hemo Component Schiller Argus Pro PB-1000 Monitor unit. Argus Pro PB 1000 firmware versions 2.41+M NIBP and 2.42.01+M. A programmable diagnostic computer intended for acquiring, digitizing, storing, displaying and reviewing hemodynamic data for use in hospital cardiac catheterization laboratories. The system is cleared for us with a component physiological data collection unit - the Schiller Argus Pro
PB 1000 Monitor unit.
Code Information: Argus Pro PB 1000 firmware versions 2.41+M NIBP and 2.42.01+M Serial numbers prefaced with PB-1000: 765.001471, 760.001566, 760.001793,760.001882, 760.001920, 760.001934, 760.001970, 760.002043, 760.002113, 765.001168, 765.001307, 765.001520, 765.001553, 765.001599, 765.001609, 765.001510, 765.001632, 765.00165, 765.003014, 760.001320, 760,001552, 760.001555, 760,001920, 760.002107, 765.001224, 765.001306, 765.001608.
Recalling Firm/Manufacturer: McKesson Provider Technologies - Medical Imaging Group 1639 State Rt 10 Ste 100 Parsippany, New Jersey 07054-4506
Reason for Recall: McKesson has recently discovered that certain Horizon Cardiology Hemo systems were running specific Schiller Argus-Pro PB 1000 firmware versions that might cause a delay in the display of physiological parameters on the Horizon Cardiology Hemo Real Time Monitor Screen.
Action: The firm, McKesson, sent an "Advisory Notice" letter dated April 15, 2010, to all customers. The letter describes the problem, products affected, and actions to be taken by customers. The customers were instructed not to use the Emergency Replacement Hemo kit until they receive a replacement Schiller Argus Pro PB-1000 and they have contacted McKesson Support department at 1-866-777-0202. If you have any questions regarding this notice, please call our Customer Support department at 1-0866-777-0202 and ask to speak to your support Manager.
Quantity in Commerce: 26 units; 19 in operational use, 8 as emergency replacement units.
Distribution: Nationwide distribution: CA, CO, MD, NH, NT, NY, TN, and TX.

"Medical & Radiation Emitting Device Recalls." FDA U.S. Food and Drug Administration. U.S. Department of Health and Human Services, 9 July 2010. Web. 18 Nov. 2010. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/resCollection_2.cfm?ID=91258&CREATE_DT=2010-07-09


Recall 2:
Date Posted: June 24, 2010
Recall Number: Z-1899-2010
Product: Horizon Cardiology Hemo Monitoring System A programmable diagnostic computer intended for acquiring digitizing, storing, displaying , and reviewing hemodynamic data for use in hospital cardiac catherization laboratories.
Code Information: Serial numbers: 2008052847, 2008072107, 2008092609,
2008092608, 2009010800, 2008121714, 2008101609, 2008101608, 2008101618,
2008110391, 2008110390, 2008110389, 2009020226, 2009020227, 2009030603,
2009030602, 2009030601, 2009110399, 2008110398, 2008051520, 2008051519,
2008051518.
Recalling Firm/Manufacturer: McKesson Provider Technologies - Medical Imaging
Group 1639 State Rt 10 Ste 100 Parsippany, New Jersey 07054-4506
Reason for Recall: McKesson has identified a potential hardware configuration problem in some Horizon Cardiology Hemo systems which may cause delay and/or loss of the patient's physiological parameters on the Horizon Cardiology Hemo screen and on the patient record.
Action: The firm, McKesson Israel Ltd., sent notification letter dated January 27, 2010 to customers. The letter describes the product, problem and action to be taken by customers and the firm. McKesson's will be contacting the customer to coordinate replacement of the sound component of the Horizon Cardiology Hemo system and will provide the additional sound adapter for all affected systems at your facility at not cost. The customers were instructed to please immediately conduct the following instructions to disable sound operations-1) Open McKesson Management Console and locate the Windsurfer>Monitor Settings; 2) Uncheck "Enable QRS beep" in the sounds section; 3) Locate Windsufer>Hardware Settings in McKesson Management Console, and 4) Uncheck "Enable QRS beep" in the Analog Output, QRS Beep Section. If you have any questions, please do not hesitate to contact Ronen Gans directly at (973) 355-9900.
Quantity in Commerce: 22 devices
Distribution: Nationwide distribution: CA, CT, FL, LA, NC, TN, WA, and WV.

"Medical & Radiation Emitting Device Recalls." FDA U.S. Food and Drug Administration. U.S. Department of Health and Human Services, 24 June 2010. Web. 18 Nov. 2010. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/resCollection_2.cfm?ID=91248&CREATE_DT=2010-06-24.


Recall 3:
Date Posted: April 10, 2009
Recall Number: Z-1156-2009
Product: NurseMate with Physio Module; Remote Review, Monitoring and Charting Station; USA EP MedSystems, Inc. Cooper Run Executive Park, 575 Route 73 North, Unit D, West Berlin, NJ 08090. Outer box labeled as Smiths Medical. The NurseMate Remote Review Station is an integrated review station for the EP WorkMate Computer recording system that allows a separate user to review and edit patient study date stored on the SP Work Mate System and monitor patient data from the EP WorkMate during a Patient study.
Code Information: Smith Medical Part Number: 87-1785-0000; Serial
Numbers: AM08080015, AM08080016, AM08080017, AM08080018, AM08080019, AM08100004, AM08100005, AM08100006, AM08100007 and AM08100008.
Recalling Firm/Manufacturer: St. Jude Medical 575 Route 73 North, Bldg D Cooper Run Executive Park West Berlin, New Jersey 08091
Reason for Recall: Installation problem: there is a risk that the monitor may not be adequately secured to the stand, resulting in the monitor falling off which may cause injury.
Action: St. Jude Medical received a recall notice dated January 16, 2009 from its supplier, Smiths Medical PM, Inc. St. Jude Medical prepared and sent their own recall letter dated February 13, 2009 to affected customers. The recall letter described the issue and possible associated risks and provided instructions to customers. A St. Jude Medical representative will contact customers to facilitate replacement of the fasteners. Questions should be directed to your St. Jude Medical sales representative.
Quantity in Commerce: 4 units
Distribution: Nationwide Distribution -- CA, NV, and FL.

"Medical & Radiation Emitting Device Recalls." FDA U.S. Food and Drug Administration. U.S. Department of Health and Human Services, 10 Apr. 2009.. Web. 18 Nov. 2010. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/resCollection_2.cfm?ID=79130&CREATE_DT=2009-04-10>


Recall 4:
Date Posted: February 05, 2008
Recall Number: Z-0710-2008
Product: Horizon Cardiology Hemo Monitoring System; Horizon Cardiology Hemo External Control Unit;~100 - 230 VAC 50-50 Hz, Medcon Telemedicine Technology LTD.,Tel Aviv, 697190, Israel.
Code Information: Serial Numbers of subassemblies (ECUs) that contain
the affected power supply: A0199, A0200, A0201, A0205, A0208, A0209, A0210,
A0225, A0232, A0233, A0234, A0235, and A0236
Recalling Firm/Manufacturer: McKesson Provider Technologies 628 State Route
10 Whippany, New Jersey 07981-1522
Reason for Recall: Power supply reliability: McKesson received word from their manufacturer of the medical grade power supply that some power grade supplies may not provide reliable power output.
Action: Recalled by letter sent to the firm's customers beginning on 11-12-2007, advising them that the field correction would be completed by the recalling firm service technicians.
Quantity in Commerce: 13
Distribution:Nationwide to hospital and medical centers in LA. CA, PA and IL,

"Medical & Radiation Emitting Device Recalls." FDA U.S. Food and Drug Administration. U.S. Department of Health and Human Services, 5 Feb. 2008. Web. 18 Nov. 2010. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/resCollection_2.cfm?ID=67098&CREATE_DT=2008-02-05


The following table lists the MedSun reports that are described in the device problem summary above.
[Note: The reports have been edited for clarity]

Adverse Events Table
Device IdentifiersCatalog #, Model #, Lot # Event Description
Biosense Webster, Carto 3 P1-40S0TY (Carto 3); P1-40SOYH (generator); P1-40S14C (Cool flow pump); P1-40S91R (navistar thermocool catheter) During an ischemic VT case, the Carto 3 system failed to correctly route pacing resulting in 3 total cardioversions that would have otherwise been unnecessary. The first instance resulted when the physician could not get the ablation catheter to pace due to failed routing. The second instance occurred as the physician could not get the pacing on the ablation catheter to disable through Carto 3, and thus RF could not be applied. In this case, the patient went into clinical VT, became unstable and required cardioversion. The third instance occurred when the user could not effectively ablatedue to a defective Redel cable. This Redel cable was reading low temperatures and the RF (radiofrequency) could not be turned on. A cable was changed and the issue was resolved. The vendor was notified along with a request for an investigation into the Carto 3 issues, especially the pace routing. The patient stabilized despite these equipment malfunctions.

Products in Use:
The Carto 3 system
The Stockert generator
The Cool Flow Pump
The Navistar Thermocool catheter.

======================
Health Professional's Impression
======================
During Ischemic VT ablation case, the Carto 3 system failed to correctly route pacing resulting in 3 cardioversions that would have otherwise been unnecessary.

======================
Manufacturer response for EP mapping system, CARTO 3 System
======================
Investigating
St. Jude Medical, EnSite Velocity with NavX The EnSite unit has three components, a control, slave monitor and an amplifier. This unit is used as a mapping system to assist the physicians in locating areas that need radiofrequency ablating. The procedure can be performed without the system, however, it is more efficient with it. With the system in use,it was not properly identifying the reference catheters. The St. Jude rep was here to support the unit until the staff are trained. While on site, the representative identified the problem with the system and contacted their technical services where they determined the problem was with the amplifier. The EnSite seemed to be mapping okay once the rep worked with it a little. There were then no questions about where the lesions were made. The reference catheter was not seen visually on the screen until you reduced the magnification. But according to the rep and my understanding, the unit recognized the reference catheter as being in the proper location. Once the rep confirmed with St. Jude's tech service that the amplifier was the problem, they made arrangements to send out a new amplifier. The new amplifier is the same type as the as the original.

======================
Health Professional's Impression
======================
The Amplifier part of system was not working.

======================
Manufacturer response for 3D Mapping (NAVX), St. Jude
======================
Company replaced equipment.

St. Jude Medical, EP MedSystems EP Med Software Version 4.1.0 The electrophysiology (EP) four channel stimulator is connected to the EP Med recorder. While pace-mapping, during a ventricular tachycardia (VT) ablation, the EP Med froze and would not respond to the "HALT pacing" button on the keyboard. Pacing continued at a rate of 250 ms (240 beats per minute) instead of stopping after three to four beats while the EP Med system lagged, it continued to pace for four seconds, sixteen beats. The patient went into rapid, hemodynamically unstable ventricular tachycardia and required 200 joule external cardioversion. VT is induced intentionally as a normal course of the procedure, but this specific episode was unintentional. The procedure continued as planned and the patient suffered no harm. This software "freeze" prevented the EP Med system from communicating with the EP-4 stimulator, so pacing could not be stopped using the usual "HALT" pacing keyboard button until the computer lag resolved (4 seconds later). The prolonged rapid pacing in the ventricle resulted in a VT that was accelerated from the patient's baseline VT and caused hemodynamic collapse.
McKesson Corporation, Horizon Cardiology Release 12.2 McKesson has identified that when reporting ECG files from Mortara ECG carts, while the DICOM interface is in use, the Horizon Cardiology ECG management system does not display the amplitudes of the waveform properly.

======================
Health Professional's Impression
======================
The ECG waveform amplitude is 20% higher or lower than it actually is in comparison to the cart printout, affecting the waveform analysis algorithm in the ECG management system. This inaccuracy may result in false negative or false positive diagnosis. Cardiologist's believe patient safety is low.

======================
Manufacturer response (according to reporter) for ECG Management, Horizon Cardiology
======================
A software patch is in test environment.
McKesson Corporation, Horizon Cardiology CE-TCSHEM003 The patient was brought to cath lab for an emergent temporary pacemaker. The monitor tech initiated the Horizon cardiology program for monitoring the patient and documenting the case. The system failed to initialize. An error message appeared "Internal". IS was contacted, but they were unable to resolve issue. McKesson support was also contacted for assistance. The situation was not resolved until case was completed. All documentation and vital signs are done manually. There was no harm to the patient.
G.E. Healthcare, CardioLab/Mac-Lab/ComboLab Hewlett Packard XW8400, 2037934-003 The CardioLab system closed out of the application and returned to the Windows desktop during a procedure. The case could not be restarted. After consulting with GE tech support, the removable DVD disk was replaced and a new case started. Tech support recommended replacing the removable DVD disk. The engineer also stated that the application will close out of the program if it can not write to the DVD disk, even in the midst of a procedure. The field engineer was dispatched, confirmed the engineer's statements and download the applications and systems logs along with the patient study.
St. Jude Medical, EnSite Velocity The mapping system was not correlating the location of the ablation catheter correctly. It was displaying movements that were clearly not taking place when we looked under fluoroscopy. The system was connected correctly and configured correctly. The rep was operating the equipment and did not understand why this was happening. Tech services was called. It appears it was a software issue. In the meantime, we've adjusted some settings and still use the system with fluoroscopic verification of catheter placement. Manufacturer response: A software patch is coming out in March to address this issue.
Biosense Webster, Carto XP CARTOXP Approximately 15 minutes after the surface EKG leads had been placed on the patient, the EKG surface lead tracings on EP MedSystems went from showing sinus rhythm to showing no tracings (flat line). All surface lead and ground connections were confirmed. The Carto XP Com unit (processing unit) was turned off and all surface lead tracings instantly returned. The Carto system was rebooted. No further incidents occurred during the remainder of the case. There was no injury to the patient.
Biosense Webster, Carto XP M-4700-96 Carto has an issue with their equipment in one of our EP labs. When creating a map using Carto, the map itself will shift on its own. At first it seems as if the patient has moved when in actuality it is a glitch in the Carto system. This has happened multiple times in this particular lab. We do not believe that this is a disposable equipment problem. It is a problem with the mapping system (CARTO) and possibly how it is interacting with the X-ray system. This is an intermittent problem that happens during ablation procedures. The problem is not a direct patient safety issue. It does necessitate the use of more fluoroscopy and lengthen the procedure time which can lead to a patient safety issue. Carto updated software to version 9. We suspect a software issue. The mapping area is detecting a larger area with this new software which includes part of the x-ray system outside of the patient.
McKesson Information Solutions LLC, Horizon Cardiology and Siemens Medical Solutions USA, Inc., Axiom Artis

Images from the Siemens Axiom Artis system are supposed to be archived automatically by the McKesson Horizon Cardiology Information system. Sometimes this does not happen. Departmental policy is that at the end of each case the monitoring tech is supposed to verify that the images have transferred over. Once the transfer and archiving is verified, the images can be deleted from the Siemens system. In this case the team member noted that the images were missing, but didn't attempt to archive them. The team member then accidentally deleted the images from Siemens. Once deleted, these images can't be recovered. The cath procedure was re-done.

Additional Information:

1. "Programmable diagnostic computer." 21CFR870.1425. 2010.

2. Summary of Safety and Effectiveness. U.S. Food and Drug Administration, Web. 18 Nov. 2010.

Nov. 2010. http://www.accessdata.fda.gov/cdrh_docs/pdf5/K050561.pdf

3. 510(K) Summary. U.S. Food and Drug Administration, Web. 18 Nov. 2010.

http://www.accessdata.fda.gov/cdrh_docs/pdf7/K072202.pdf

4. Chapter 2 - 510(k) Summary. U.S. Food and Drug Administration, Web. 18 Nov. 2010.

http://www.accessdata.fda.gov/cdrh_docs/pdf6/K061905.pdf

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Updated December 1, 2010

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