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U.S. Department of Health and Human Services

MedSun: Newsletter #44, January 2010

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Newsletter #44, January 2010

Articles

Thermoflect Blankets and product line - Recall

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FDA MedWatch Safety Alert

Encompass Group and FDA notified healthcare professionals of the voluntary recall of the Thermoflect product line for relabeling regarding its use in the MR (Magnetic Resonance) environment. FDA has recommended that the Thermoflect blankets and other products not be used in MR conditional or MR compatible environments.

Additional Information:

FDA MedWatch Safety Alert. Thermoflect Blankets and product line - Recall. December 28, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm195703.htm

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CT Brain Perfusion Scans Safety Investigation: Initial Notification

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FDA MedWatch Safety Alert

The FDA, working with state and local health authorities, has identified at least 50 additional patients who were exposed to excess radiation of up to eight times the expected level during their CT perfusion scans. These cases so far involve more than one manufacturer of CT scanners. Some of these patients reported hair loss or skin redness following their scans. High doses of radiation can cause cataracts and increase the risk of some forms of cancer. On the basis of its investigation to date, the FDA is providing interim recommendations for imaging facilities, radiologists, and radiologic technologists to help prevent additional cases of excess exposure.

Additional Information:

FDA MedWatch Safety Alert. CT Brain Perfusion Scans Safety Investigation: Initial Notification. December 7, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm186105.htm

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Steris System 1 Processor: FDA Notice and Recommendations

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FDA MedWatch Safety Alert

FDA notified healthcare facility administrators and infection control healthcare professionals of important information regarding the regulatory status of the STERIS System 1 Processor (SS1) used in surgical and endoscopy suites for reprocessing, i.e., sterilizing or disinfecting, medical devices. STERIS has significantly modified the SS1 and FDA has not approved or cleared this modified product. Thus, FDA has not determined whether the SS1 is safe or effective for its labeled claims, including claims that it sterilizes medical devices. FDA recommends that if a facility has an acceptable alternative to the SS1 to meet sterilization and disinfection needs, the facility should transition to that alternative as soon as possible to ensure continued patient safety. If an acceptable alternative to the SS1 is not available, the facility should promptly assess its patient-care needs and sterilization and disinfection requirements and take steps to obtain legally-marketed substitutes for the SS1.

Additional Information:

FDA MedWatch Safety Alert. Steris System 1 Processor: FDA Notice and Recommendations. December 3, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm192842.htm

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CDC Guidelines for Infection Control

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Premier Safety Share

Infection prevention and control guidelines and recommendations from the Centers for Disease Control and Prevention (CDC) and Healthcare Infection Control Practices Advisory Committee (HICPAC) are available from the CDC site. Other recommendations included are: injection practices for patient safety, bloodsteam infection information, and public reporting of healthcare-associated infections. Also in the additional information section is a recent communication from FDA, CDC, and the VA on preventing cross-contamination in endoscope processing.

Additional Information:

CDC guidelines for infection control. Premier Inc. 2009.
http://www.premierinc.com/quality-safety/tools-services/safety/topics/guidelines/cdc_guidelines.jsp

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

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Do Community Wristbands Present a Patient Safety Risk?

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Pennsylvania Patient Safety Authority

There is potential for confusion between community wristbands and hospital color-coded wristbands if the community wristbands are inadvertently interpreted as hospital wristbands. This could result in inadequate or incorrect care being delivered to patients, particularly in emergent situations. Facilities may consider prohibiting community wristbands in the healthcare setting. If patients do not consent to the removal of these community wristbands, covering them may be a viable alternative.

Additional Information:

Pennsylvania Patient Safety Authority. Do Community Wristbands Present a Patient Safety Risk? December 2009.
http://www.patientsafetyauthority.org/ADVISORIES/AdvisoryLibrary/2009/Dec6(4)/Pages/140.aspx

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LabNet

Recommendations for Diagnosis of Shiga Toxin - Producing Escherichia coli Infections by Clinical Laboratories

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CDC MMWR

This report provides comprehensive and detailed recommendations for Shiga toxin--producing Escherichia coli (STEC) testing by clinical laboratories, procedures for specimen selection, handling, and transport; a review of culture and nonculture tests for STEC detection; and clinical considerations and recommendations for management of patients with STEC infection. Improving the diagnostic accuracy of STEC infection by clinical laboratories should ensure prompt diagnosis and treatment of these infections in patients and increase detection of STEC outbreaks in the community.

Additional Information:

CDC MMWR. Recommendations for Diagnosis of Shiga Toxin – Producing Escherichia coli Infections by Clinical Laboratories. October 16, 2009.
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5812a1.htm?s_cid=rr5812a1_e

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Differential Anemia Diagnosis: What's the Best Marker of Iron Status?

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AACC Clinical Laboratory News

Even with such a profound disease burden, iron deficiency anemia (IDA) and anemia of chronic disease (ACD) often receive sub-optimal clinical management. Strategies to definitively diagnose and treat the conditions have not been widely implemented, and there is disagreement about the best combination of tests and cutoff points to distinguish between the two. At the same time, research advances have enhanced the field’s understanding of iron homeostasis, and ushered in a new generation of analytical tools with their own set of challenges.

Additional Information:

AACC Clinical Laboratory News. Differential Anemia Diagnosis: What’s the Best Marker of Iron Status? November 2009.
http://www.aacc.org/publications/cln/2009/november/Pages/CoverStory2Nov09.aspx

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Drain Disposal of Chemicals

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The Lab Manager Magazine

This article gives recommendations on proper drain disposal of chemicals. Including, be certain that the sewer flows to a wastewater treatment plant and not to a stream or other natural water course. For compounds not suitable for drain disposal, label and package the compound and ship by a shipper approved by the U.S. Department of Transportation to a landfill designated by EPA to receive chemical and hazardous waste.

Additional Information:

The Lab Manager Magazine. Drain Disposal of Chemicals. October 22, 2009.
http://www.labmanager.com/stips.asp?ID=87

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SightNet

Corneal Abrasion Injuries

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Pennsylvania Patient Safety Authority

Corneal abrasion is the most common ocular injury occurring in the perioperative period. Most of the Pennsylvania Patient Safety Authority reports (81%) were recognized in the perioperative setting. However, 19% of the reports occurred in diverse care areas such as the medical intensive care unit, the emergency department, on telemetry floors, in radiation oncology, and in labor and delivery wards, leading to the conclusion that all staff should be able to quickly identify, report, and treat corneal abrasions. The lack of information about corneal abrasions prevents the Pennsylvania Patient Safety Authority from making new insights about this problem. Reports that are more detailed might be helpful in determining how and why these injuries occur.

Additional Information:

Pennsylvania Patient Safety Authority. Corneal Abrasion Injuries. December 2009.
http://www.patientsafetyauthority.org/ADVISORIES/AdvisoryLibrary/2009/Dec6(4)/Pages/144.aspx

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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 October 1 through October 31. 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: Suction Catheter W/sleeve Delee Tip 8Fr
Manufacturer: MEDLINE Industries
Brand: Medline
Model#: DYND40708/2
Lot #: 09BG2114
Cat #: (not provided)
Other #: REF

Problem:
Suction catheter pinched at end so unable to appropriately and completely suction trach. Mother described that she was unable to "suction anything" using catheter with pinched opening. Three other catheters were removed from our on-floor, secure supply/meds distribution center that also appeared to have pinched openings.


CARDIOVASCULAR

Device:

Type: Cable, Temporary Pacing, Disposable
Manufacturer: Remington Medical, Inc.
Brand: Adap-2000
Model#: (not provided)
Lot #: 090274
Cat #: (not provided)
Other #: (not provided)

Problem:
During temporary pacing with the Remington Medical disposable adapter, ADAP-2000 and a compatible temporary pacer box, the patient intermittently developed a loss of capture despite maximum output and confirmation by X-ray of proper pacing wire placement. Also, the pacing adapter did not fit into pacemaker well and had to be forcibly removed from the head of the pacer at the end of the case. It seemed to be stuck in place. This problem was found very quickly.

The patient’s permanent pacemaker was reattached and the patient had a good outcome. The temporary pacer box was tested and was not part of the problem. We have never had problems with this adapter before but this is one of two reports which occurred on the same day. There seems to be a problem with this lot. We have removed all adapters with this lot in our hospital system.

Manufacturer's response (per reporter):

They have received complaints about the adapter not fitting well. There is definitely a problem with this lot. Our facility's complaints were the first complaint about a patient being affected due to this. We have pulled all adapters with this lot number in our hospital system.


Device:

Type: Closure Device
Manufacturer: AccessClosure, Inc.
Brand: Mynx
Model#: (not provided)
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
Failed Mynx closure device. Manual hemostasis was required with subsequent femstop placement.
When deploying the Mynx closure device, the balloon failed to deflate. When attempting to remove the device from the patient, the balloon sheared in the tissue tract. Hydroseal was deployed in the tissue tract properly. When the wire and advance tube were removed, the balloon was not on the wire.


Device:

Type: Lead, Pacing, Left Ventricular
Manufacturer: St Jude Medical Cardiac Rhythm
Brand: Quickflex Xl
Model#: 1158T-86
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
Briefly, this patient is an adult female with a history of cardiomyopathy and recent implant of CRT-D. The patient had noted right atrial (RA) lead dislodgement few days following the recent implant. The patient was seen and examined by an electrophysiology staff physician and deemed appropriate for lead revision. Her atrial lead was repositioned to more lateral position, which demonstrated more stable appearance and better sensing. In the process, her LV lead was dislodged and a new LV lead had to be placed. The LV lead had an insulation break and therefore, was abandoned. A new lead of similar type was placed in the anterior lateral branch. There was no negative outcome to the patient; she recovered from the procedure and was discharged home the following day.


Device:

Type: Lead, Temporary, Bipolar Myocardial Pacing Wire
Manufacturer: Medtronic Inc., Cardiac Rhythm Disease Management
Brand: Streamline
Model#: (not provided)
Lot #: TCA507305F
Cat #: (not provided)
Other #: (not provided)

Problem:
The pacing wire was being placed on the heart when the needle broke off the wire. The needle was lodged in the heart and could not be removed. The surgeon attempted to dissect the heart to remove needle. The surgeon could feel the needle but the risks outweighed the benefit of removing the needle.


Device:

Type: Limb, Sleeve, Compressible
Manufacturer: Medical Compression Systems (MCS)
Brand: Active Care Dvt
Model#: 1469
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
Intermittent pneumatic compression device was attached to patient's stockings and the machine was turned off. When turning the device back on, it immediately smelled of burning plastic, felt hot and the device became soft around the light on top of the unit. It was immediately removed from use. The device was plugged-in at the time of the event, it was not running on battery power.

See device images

Pneumatic Compression 1

Pneumatic Compression 2

Pneumatic Compression 3

Pneumatic Compression 4

Pneumatic Compression 5

Pneumatic Compression 6



GASTROENTEROLOGY & UROLOGY

Device:

Type: Foley Catheter
Manufacturer: CR Bard
Brand: Bard
Model#: TRAY #897216
Lot #: NGTE1354
Cat #: 897216
Other #: (not provided)

Problem:
Order received to discontinue foley catheter. The catheter balloon was deflated, and began withdrawing the catheter. Resistance was encountered and stopped. A syringe was used to withdraw balloon port again. No fluid left in balloon. Unable to slide catheter out as expected because of resistance met. MD into room to lubricate catheter, and still met resistance. MD had to withdraw catheter past point of resistance, which was very uncomfortable per patient. When MD finally was able to remove the catheter, we noted a “cuff” remained at section of catheter where balloon is. Opened new indwelling foley kit to examine catheter and it appeared normal until balloon was inflated then deflated. Cuff appeared on new catheter as well. Lot # NGTE1354 Exp. 3/2012. Opened another foley catheter kit of a different lot #, this catheter did not form a “cuff” with inflation/deflation. Patient was placed on an antibiotic after difficulty with removal.
Purchasing Manager notified and removed all Lot # NGTE1354’s from service and notified Bard Rep. Purchasing Manager spoke with Bard Quality Control rep. who response was “that can be a factor with the silicon product”.


Device 1:

Type: Lead
Manufacturer: Medtronic Neuromodulation
Brand: Interstim Lead
Model#: 3093 33 cm
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)


Device 2:

Type: Stimulator, Electrical, Implantable, For Incontinence
Manufacturer: Medtronic Neuromodulation
Brand: Interstim
Model#: 3058
Lot #: (not provided)
Cat #: (not provided)
Other #: InterStim II Generator

Problem:
Patient with urinary frequency and urge incontinence. Pt had InterStim generator and InterStim lead placed 1yr 3 months ago. Device worked well and then there was an abrupt onset of inefficacy of the device. Patient chose to have device explanted and new device implanted. In the OR the device was tested and there was a complete loss of communication through the lead to the stimulator.


Device:

Type: Tray, Foley Catheter
Manufacturer: Bard Urological Division
Brand: Bardex I. C. Complete Care
Model#: h302903016a06
Lot #: NGTH0974
Cat #: 903016A
Other #:

Problem:
Foley catheter checked prior to patient use and unable to inflate balloon. The inflation occurred in the pigtail where the syringe was inserted, before it got to the main part of the catheter. It looks like the spot where the pigtail goes into the main part of the catheter does not have an opening.

When attempting to inflate balloon, the catheter inflated at the instillation port. Several more from the same lot had been used today, but this is the only one defective.

See device images

Foley Catheter 1

Foley Catheter 2

Foley Catheter 3


GENERAL & PLASTIC SURGERY

Device:

Type: Breast Biopsy Marker
Manufacturer: Ethicon Endo-Surgery, Inc.
Brand: Mammomark
Model#: mam3001
Lot #: F4PE21
Cat #: (not provided)
Other #: 000719800765405/+H208mam30011+/+11031F4Pe21K

Problem:
After clip deployed, could not get sheath out. End cap of plunger came off. MD pulled back, rotated 180 degrees, took film, clip there, removed sheath. Plastic tip of casing that houses plunger was found to be missing - not known if sheared off in patient's breast or as part of clean up.


Device 1:

Type: Catheter, Biliary
Manufacturer: ConMed Endoscopic Technologies
Brand: Pro-forma Cannula
Model#: (not provided)
Lot #: 0908051
Cat #: (not provided)
Other #: (not provided)

Device 2:

Type: Catheter, Biliary
Manufacturer: ConMed Endoscopic Technologies, Inc.
Brand: Proforma Cannula
Model#: (not provided)
Lot #: 0811171
Cat #: (not provided)
Other #: (not provided)
Problem:
During ERCP (Endoscopic retrograde cholangiopancreatography), the ConMed Pro-Forma catheter was removed and the radiographic tip was noted to be missing from the end of the catheter. The radiographic tip was identified still within the body; a new/different catheter with snare was introduced and the radiographic tip was successfully retrieved. Since this episode, we have opened two other kits of the same catheter and found the radiographic tip "off" in the package. We have since stopped using this catheter and given feedback to the manufacturer regarding this ongoing problem.


Device:

Type: Surgical Graft
Manufacturer: Davol, subsidiary of CR Bard
Brand: Xenmatrix
Model#: (not provided)
Lot #: HUTFBL03
Cat #: ref 1161935
Other #: exp date 06/2011

Problem:
The surgeon explained that this product had been presented by the company sales representatives as having "good results" when used in contaminated wounds.

This patient with a complicated abdominal history and multiple prior surgeries had bowel obstruction and internal hernia. The patient had lysis of adhesions and her abdomen was left open at the end of that procedure. The patient returned to operating room three days later for abdominal washout and cholecystectomy (mass was identified on gallbladder during the first operation).

Four days later, the patient returned to the operating room for final washout and closure of abdomen with XenMatrix porcine mesh placement and the skin was closed over the mesh. Subsequently, the incision started to drain which was initially thought to be fat necrosis and seroma, but began to look more purulent.
Five days later, the surgeon removed sutures from the skin and opened the incision to find the mesh had melted / completely disintegrated; the patient was eviscerating. Pt was taken to the operating room emergently for wound washout and wound VAC placement and has since undergone 4 more abdominal surgeries and remains in the surgical intensive care unit.

Manufacturer response (as per reporter) for surgical graft, XenMatrix:

The mesh should NOT be used with infected wounds.

Of note, the wound was not known to be contaminated at the time the mesh was placed.


Device:

Type: Table, Operating
Manufacturer: Mizuho Orthopedic Systems Incorporated
Brand: Jackson
Model#: 5892
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
A patient was in the prone position on the Jackson table. During surgery, the surgeon asked the anesthesiologist to tilt the bed towards the patient's left side. The bed was unlocked and it flipped. The patient slid to the floor, was extubated and the intravenous catheter came out. The patient was reintubated immediately and lifted back onto the table. The open wound was copiously irrigated.


GENERAL HOSPITAL

Device:

Type: Bed, Hospital
Manufacturer: Kinetic Concepts, Inc.
Brand: Kinair
Model#: MedSurg
Lot #: (not provided)
Cat #: 201001W
Other #: (not provided)

Problem:
Patient was in Fowler position when bed deflated and patient's right arm became entrapped in the top right with rest of body off the bed. Patient found to have fractured shoulder.


Device:

Type: Catheter, Iv
Manufacturer: BD (Becton Dickinson)
Brand: Insyte Autoguard
Model#: 381444
Lot #: 9107580
Cat #: (not provided)
Other #: (not provided)

Problem:
RN was inserting the 18g autoguard for large bore IV access; inserted without difficulty. However, when the nurse pressed the needle retract button on the side, the IV catheter came apart from the green hub and retracted back with the needle. There was no harm to the patient or healthcare provider.


Device:

Type: Infusion Pump
Manufacturer: IRadimed
Brand: Mridium 3860
Model#: 3860
Lot #: (not provided)
Cat #: (not provided)
Other #: Control # 220073

Problem:
IRadimed IV pump gave a "critical error 1002" causing the pump to shut down. The amount of infusion to that point was correct. The patient did not receive the infusion for approximately 5 minutes, but did not awaken. The infusion was restarted on another pump.

Manufacturer response (as per reporter) for MRI IV Pump System, MRidium 3860

IRadimed service technician informed our facility that critical error 1002 is a known issue that occurs when the processor and controller do not properly sync. This issue could be caused by noise. Instructions for checking history log were given.


Device:

Type: Intrathecal Pump
Manufacturer: Medtronic Neuromodulation
Brand: Synchromed
Model#: unknown
Lot #: unknown
Cat #: unknown
Other #: (not provided)

Problem:
An Advanced Practice RN read an obituary notice in the paper for one of the patients that she had recently cared for in the hospital. She noted that the obituary discussed that the patient would be cremated and she recalled that the patient had a pain pump inserted just prior to discharge on the patient's last visit. She called the crematorium and asked if they were aware that the patient had this implanted device. They were not; and noted that they were just getting ready to begin the cremation. They were able to halt the process and remove the device before proceeding. Implanted devices with batteries can explode during the cremation process, which poses a danger to those who work at such facilities not only from the explosion, but also from the radiation that can be released. The explosion is also forceful enough that the crematorium itself can be significantly damaged. In addition, the terminology funeral homes/crematories use with families to screen for devices is very leading and specifies "pacemaker" rather than a generic question about any implanted device. Implanted devices are not always easy to identify on a simple screen of the body itself and might not be identified during the funeral home's investigation of the body. They usually catch obvious palpable devices, scars in obvious locations (chest - pacer), or bodies that are "beeping" for unknown reasons - their words, specifically.

The nurse notified the manufacturer, who confirmed that the device can explode if it remains in a body during cremation.


Device:

Type: Iv Solution
Manufacturer: Hospira Worldwide
Brand: Lactated Ringer's Injection Vis-iv
Model#: (not provided)
Lot #: 80-277-JT
Cat #: 0409-7953-48
Other #: 1203012

Problem:
Nurse spiked the IV bag in the designated (white) port. Seal leaked around the spike. Nurse obtained another bag and IV administration set and spiked the new bag without incident. No adverse event.

Nurse discarded bag and set in question. We believe [but are NOT CERTAIN] that bag was from lot # 80-277-JT.

Manufacturer response (as per reporter) for IV solution, Lactated Ringer's Injection Vis-IV:

Have not received call or e-mail from sales representative.


Device:

Type: Iv Tubing
Manufacturer: Medrad, Inc.
Brand: Continuum Mr Infusion System Standard Administration Kit
Model#: MIK200A
Lot #: (not provided)
Cat #: MIK200A
Other #: (not provided)

Problem:
An ICU patient was in MRI having diagnostic exam performed when he experienced a severe drop in his blood pressure. The accompanying ICU RN stated the patient's MRI safe IV pump began to alarm "air in line" about 15 minutes after the MRI IV specialty tubing had been attached. The pump was switched out, and the RN attempted to clear the line again, and the new pump alarmed "air in line." The RN stated she was unable to clear the line quickly enough before the patient's blood pressure and heart rate decreased, which warranted a code to be called (patient did not have full arrest). The patient's blood pressure dropped severely low. The RN stated she then had to push IV Norepinephrine until new IV tubing set could be primed and set up through the MRI pump. The RN stated that once the patient was stabilized, she was able to go back and look at the original tubing and noticed fluids were leaking from the connection hub. The RN believes this is the cause of patient not getting his required medication, and also feels there was no pump issues as the second set of tubing functioned properly through the MRI pump.


Device:

Type: Iv Tubing
Manufacturer: B. Braun Medical, Inc.
Brand: Ultrasite Outlook Safety Infusion System Iv Set
Model#: 470042
Lot #: (not provided)
Cat #: (not provided)
Other #: US1504HP

Problem:
It has been brought to our attention our staff have been receiving an increase in "System Error 9" alarms from our B. Braun Outlook 100 pumps. Correspondence from B. Braun indicates they have tested various factors that could be contributed to the System Error 9 alarms resulting from the IV pump sets. Typically once the IV tubing is switched out the issue is remedied. B. Braun’s correspondence indicates their (quoted from letter) "testing to date has identified on a small percentage of IV set pump cassettes, the fluid channel was deformed during the manufacturing process. When these sets are placed into the Outlook and/or NXT pump, a system error 9 alarms may occur. The channel deformation has been determined to be a result of the properties of the resin material that was used to mold the rigid cassette. Use of this particular lot of resin has been discontinued." B. Braun has also indicated they will continue to work through this issue.

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


Device 1:

Type: Iv Tubing
Manufacturer: CareFusion Healthcare Cardinal Health
Brand: Smartsite Extension Set
Model#: (not provided)
Lot #: (not provided)
Cat #: 20337E
Other #: (not provided)

Device 2:

Type: Needleless Valve
Manufacturer: CareFusion Healthcare Cardinal Health
Brand: Smartsite Positive Bolus Needle-free Valve
Model#: (not provided)
Lot #: (not provided)
Cat #: 3000E
Other #: (not provided)

Problem:
We currently use the Alaris SmartSite Extension Set used in conjunction with the Alaris SmartSite Positive Bolus Needle-Free Valve. Several incidents have been reported where the product is noted to be leaking between the extension set hub and the needle-free valve. Closer examination revealed a crack in the hub of the extension set. The most recent event was noted while a patient was being repositioned from prone to supine. As the patient was turned, blood was noted on the patient and bedding. A crack in the extension set had allowed for blood to back up in the tubing.

Manufacturer response (as per reporter) for Connection Lock, SmartSite Positive Bolus Needle-Free Valve

CareFusion has been made aware of this situation. Our facility has also provided them with product so they can investigate further.

Manufacturer response (as per reporter) for Smallbore Tubing, SmartSite Extension Set

CareFusion has been made aware of this issue. We have also returned the product so they can investigate this issue.


Device:

Type: Syringe, Prefilled, With Safety Needle
Manufacturer: Becton, Dickson and Company
Brand: Bd Safety Glide
Model#: 25 G 1"
Lot #: 8354601
Cat #: 305916
Other #: (not provided)

Problem:
The flu shot injection came in a prefilled syringe. The safety needle was taken from the box and attached to the syringe in the normal fashion. The flu shot was administered per protocol. When the needle was removed from the employee's arm, the plastic safety portion of the needle remained attached to the syringe but the needle portion remained in the arm. A small portion of the needle was visible and able to be grasped so was then removed manually and discarded.
It happened twice for two patients using the second device from same lot.


NEUROLOGY

Device:

Type: Aneurysm Clip
Manufacturer: Aesculap, Inc.
Brand: Avm Mikroclip Phynox
Model#: (not provided)
Lot #: 51407939
Cat #: FE924K
Other #: (not provided)

Problem:
Three AVM Microclips packaged as "non-sterile" were used during surgery without being sent through sterile processing. There is concern that all other AVM clips supplied to our hospital by this manufacturer are packaged similarly and marked "Sterile" and our concern is the "Non Sterile" marking should be much more conspicuous.

This is not a new product, as we have carried it for a couple of years. However, it had only been used two times before at our facility. The surgeon elected this AVM clip because its size was compatible with the very small vessel he was clipping. The product insert recommends autoclave sterilization. Our protocol now is that these clips will be stored separately in our sterile processing department.

This patient was placed on prophylactic IV antibiotics after the error was discovered and the surgeon will do CT studies 6-months post-op to rule-out infection.


OBSTETRICS/GYNECOLOGY

Device:

Type: Monitor, Fetal, Maternal
Manufacturer: GE Healthcare
Brand: (not provided)
Model#: 129
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
A patient in family birthing was receiving an epidural and her vitals were not taken for 1.5 hours. The FBC staff reported that the maternal/fetal monitor that was monitoring the patient's vitals appeared to be leaking and did not alarm. Biomed tested the unit and found that the blood pressure connectors were not connected properly thereby creating the leak. The alarm on the maternal/fetal monitor was also set to “off” and the volume was set to “1”. The maternal/fetal monitor’s alarm was reset to “on” and the volume to “5” to match other systems throughout the birthing center. All settings mentioned are controlled by the clinician. The proper setting was explained to the head nurse and training was offered to the birthing staff.


Device:

Type: Vacuum Assisted Delivery System
Manufacturer: Clinical Innovations, Inc.
Brand: Kiwi
Model#: Kiwi Omni Cup H833 VAC
Lot #: 090722
Cat #: VAC-6000M
Other #: (not provided)

Problem:
Doctor was using the flat Kiwi to help deliver the infant's head during a c-Section when it broke apart. A second Kiwi was opened and infant's head was delivered. An observing resident wrote - "Used during a c-section; used/placed according to manufacturer's recommendations. Was not using very much pressure when tubing detached, early on - just after application of vacuum."

Manufacturer response (as per reporter) for Complete Vacuum delivery System with palm pump, Kiwi Omni Cup:

This instance just happened today. This is the first time the device was saved. In the past, the company stated they could not decipher what went wrong.


ORTHOPEDIC

Device:

Type: Arthroscopic Shaver, Blade
Manufacturer: Ascent Healthcare
Brand: Gator
Model#: ES-9263A
Lot #: 756924 - Ascent Lot#
Cat #: 9263A
Other #: (not provided)

Problem:
A 4.2mm arthroscopic shaver, remanufactured by Ascent, began to leave what appeared to be metal shavings in the patients knee during an arthroscopy of the knee. This was noticed immediately by the surgeon and the shaver's use was discontinued. A new product was obtained that had not been remanufactured. The debris was suctioned out and irrigated. The procedure continued without incident.

Manufacturer response (as per reporter) for shaver blade, Gator

Made Ascent aware of incident. They have not provided much feedback until they are able to evaluate the blade. They did say that based on their experience this type of damage is caused by excessive force on the blade.


Device:

Type: Screwdriver, Orthopedic
Manufacturer: Orthofix
Brand: Pccp
Model#: (not provided)
Lot #: (not provided)
Cat #: 184000
Other #: (not provided)

Problem:
Vendor tray brought in for procedure. Sterile processing department technician went through tray with vendor and asked the manufacturer representative if there were any trouble areas with the instruments and if the instruments came apart. The rep replied no. The tray was processed through decontamination, wrapped and sterilized for a case the next day. The scrub tech was examining the tray before the procedure and took apart a screwdriver. There was blood between the two parts. The two parts were taken to decontamination to reprocess. In decontamination, the screwdriver came apart even further into three parts. There was debris between those parts also. This occurred prior to reaching the sterile field - so never reached the patient, but did cause a delay in the case.


Device:

Type: Suture, Shoulder, Absorbable
Manufacturer: Mitek
Brand: Lupine
Model#: Unknown
Lot #: 3313661
Cat #: Unknown
Other #: Lupine BR Anchor w/DS Orthocord ref # 210712

Problem:
The fixation device known as the Lupin BR Anchor w/ DS Orthocord malfunctioned and broke after insertion resulting in removal and delay of completion of procedure. The physician taps device into place, tip broke off. A new anchor was used to complete the procedure. Went to bio corkscrew anchor. Also did use 5 other lupine anchors.


RADIOLOGY

Device:

Type: Diagnostic Ultrasound Unit
Manufacturer: Siemens Medical Solutions USA, Inc.
Brand: Sonoline Adara
Model#: GM-6705A2A00
Lot #: (not provided)
Cat #: (not provided)
Other #: Hospital assigned # 921080

Problem:
Three patients had needle prostate biopsies by locum physicians who were not familiar with the Sonoline Adara, Siemens Diagnostic Ultrasound System. All three cases ended up not containing all prostate tissue. Two of the patients returned for follow up prostate needle biopsies which were also negative. The third patient had low PSA test results and elected not to have the procedure repeated at this time. The Section Head of Urology has changed practice, prohibiting any locum from using the ultrasound machine until they are signed off by him.


Device:

Type: Gamma Probe Cover
Manufacturer: Tech Medical Services, Inc.
Brand: Gamma Probe Cover
Model#: (not provided)
Lot #: C1853
Cat #: PS- 6000
Other #: (not provided)

Problem:
A new Navigator was being trialed for sentinel node biopsies on this patient. We used the probe cover that was given to us by the vendor. This cover is much thinner than the previous model. At the end of the case, it was discovered to have broken open at its tip which exposed the patient to the unsterile metal on the neoprobe in her right axilla.


Device:

Type: Imaging Plate, Computed Radiography
Manufacturer: Konica-Minolta Medical Imaging USA, Inc.
Brand: Resius 190 Xpres
Model#: Resius 190 XPRESS
Lot #: (not provided)
Cat #: (not provided)
Other #: 14 inch X 17 inch plate

Problem:
Of the 108 plates put into use, 60 plates have developed flaws or artifacts. These artifacts if not detected could result in additional diagnostic testing and potential harm.

Beginning in Sept 2007, this facility returned 28 of the 43 14" X 17" plates under warranty to Konica and received replacement. Subsequently an additional 41 plates were found to be flawed.
Konica told this Hospital that no other facilities have reported this type of issue.

The artifact on the imaging plates appears as a small area(s) of higher attenuation that can be mistaken for calcification.

We believe that the cause may be chips of glue which fall between the cover and the imaged storage plate. The glue is used to hold the metal frame surrounding the cassette.

See artifact test film and image showing calcification

Imaging Plate Artifact Test Film

Imaging Plate Artifact AP Abd



Device:

Type: X-ray System, Biplane, Vascular And Interventional
Manufacturer: GE Medical Systems, LLC
Brand: Innova 3131 Iq
Model#: 3131 IQ
Lot #: (not provided)
Cat #: S18831AM
Other #: (not provided)

Problem:
Multiple issues with this piece of equipment in which the GE Innova 3131 Biplane Imaging System was used during neuro interventional procedures. In one instance there was image artifact, in other instances there were lateral plane positioning errors and there was event in which there was an inability to perform 3D acquisition.

Manufacturer has been very responsive is working closely with us and has agreed to replace major parts of the equipment.


Device:

Type: X-ray Unit, Portable
Manufacturer: Siemens Medical Solutions USA, Inc.
Brand: Mobilett Xp Hybrid
Model#: 7742294
Lot #: (not provided)
Cat #: (not provided)
Other #: (not provided)

Problem:
The portable X-ray unit had just been used to complete a chest X-ray, and the unit had been removed from the patient's room. The unit was being transported down the hallway through the Respiratory Therapy Department when the Radiologic Technologist heard a noise from the unit and noticed black smoke and sparks emitting from the unit. The Radiologic Technologist let go of the handle and called for help. A BioMed employee was present and extinguished the fire.

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Medical Device Problem Summaries

Summary of MedSun Reports Describing Adverse Events Concerning Cochlear Implants

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A cochlear implant is a small, complex electronic device that can help to provide a sense of sound to a person who is profoundly deaf or severely hard-of-hearing. The implant consists of an external portion that sits behind the ear and a second portion that is surgically placed under the skin (see figure). An implant has the following parts:

-A microphone, which picks up sound from the environment.
-A speech processor, which selects and arranges sounds picked up by the microphone.
-A transmitter and receiver/stimulator, which receive signals from the speech processor and convert them into electric impulses.
-An electrode array, which is a group of electrodes that collects the impulses from the stimulator and sends them to different regions of the auditory nerve.
An implant does not restore normal hearing. Instead, it can give a deaf person a useful representation of sounds in the environment and help him or her to understand speech. [1]

Over the past 2 years, MedSun has received 9 adverse event reports associated with cochlear implant devices from the following 2 manufacturers: Advanced Bionics LLC (5) and Cochlear Americas (4). The reports were submitted by 5 hospitals between July 2007 and July 2009.

The reported device problems were:
• Defective electrodes (4)
• Makes distracting buzzing noise (1)
• Bone growth over device (1)
• Device failed impedance testing (1)
• Electronic chip in device failed (1)


Of the reports that listed patient age, 3 had a patient age listed as less than 21 years and 5 had a patient age listed as greater than 21 years. Of the reports that listed patient gender, a total of 2 reports involved female patients and a total of 5 reports involved male patients.

These MedSun reports contributed to FDA awareness of the device problems.


[Note: The reports have been edited for clarity]

Adverse Event Reports
Device Device Identifiers (model, catalogue number, lot) Event Description
Cochlear Americas/Nucleus Freedom Nucleus Contour device/None /None Patient with a history of traumatic brain injury and hearing loss status post his trauma. He had minor benefit after cochlear implantation and the implant was found to have defective electrodes.
Cochlear Americas/Nucleus Freedom CI24RE/None/None Patient is an adolescent with bilateral cochlear implants. His right side was implanted when he was a toddler. His left side was implanted ~3 years ago. More recently, his older right implant has been functioning poorly for him. It does not provide him with useful sound and makes distracting noises. He notes that last fall, he began noticing a "bumblebee" bubbling sound in the right cochlear implant. In spite of adjustments to his MAPS, this would not go away. He had his processor upgraded on the right and this did not improve things. He now feels that he cannot tolerate this. He wears his processor so that he does not get in any trouble, but leaves it turned off. His parents are very frustrated with this. They want him to benefit from both implants. They also feel that there has been a recent decline in his performance in school, which they think might be due to his right implant not being utilized. He underwent integrity tests by Cochlear Corporation ~5 months ago. The test was interpreted as normal. Recently, the patient came in to have his existing right side device explanted, and replaced with a new one. The device was explanted as defective and sent to Biomedical Engineering.
Advanced Bionics LLC/HiRes 90K Cochlear Implant C1-1400-01/None/None Per explanting surgeon the device was known to fail. Surgeon had been notified several years ago by the manufacturer of a voluntary recall. We waited until the device did fail before removing and replacing it with a new cochlear implant.
Cochlear Americas/Nucleus Contour (Freedom)-Cochlear CI24RE(CA)/None/None Patient underwent left cochlear implantation ~3.5 years ago. Patient's outcome with the implant was never very good and it deteriorated as time when on. Subsequent integrity testing revealed an extensive electrode abnormality.
Cochlear America/cochlear implant None/ REF Z60353 (Z6060353)/None After it was implanted, the cochlear implant device impedance was not measurable. It was subsequently explanted, and the surgeon used device back-up, which was supplied for this patient. No harm to patient.
Advanced Bionics Corporation/HiRes 90K Cochlear Implant CI-1400-01/None/None The chip in the Bionics cochlear implant was having problems, per patient's MD.
Advanced Bionics Corporation/Hi Resolution Bionic Ear System CI-1400-02H/None/G0994 One of the apical electrodes was unusually rotated. The tip of the electrode was not straight even with the stylet in place. Unable to proceed with implant placement.
Advanced Bionics Headquarters/Clarion-cochlear implant AB-5100r right/None/None Patient had a right cochlear implant performed using the Clarion 1.2 device eight years ago. After a satisfactory initial performance, patient suffered a recent device failure and presents for elective revision surgery. There was dense new bone formation over the mastoid and the feedthrough of the cochlear implant electrode. The device itself appeared normal upon extraction. There was a slight recurrence of slow outflow of cerebrospinal fluid from the cochleostomy after the implant electrode was extracted.
Advanced Bionics Corporation/cochlear implants C124RE-005/None/None The right cochlear implant showed gradual device malfunction and failed integrity testing. Patient presented for an elective revision of the implant. The electrodes were damaged during the extraction of the implant. The implant was then extracted from the cochleostomy site without difficulty.




The above list of reports may or may not have contributed to the following device recalls


Recall Information
Product NameRecall Class Date Posted Recalling Firm Reason for Recall
HR90K Platinum Series Headpiece Model Number AB-7300-001 ADVANCED BIONICS LLC 12740 San Fernando Rd.... 2 Feb-03-2009 Advanced Bionics LLC Mistuned headpiece - Advanced Bionics recently became aware of a tuning issue with some Platinum Series and S-Series headpieces shipped from May 2007 through April 2008. Tuning refers to the process through which the headpiece's communication frequency is adjusted to match that of the internal device. Potential clinical symptoms include: -No lock -Intermittent lock -Implant locks, but cann
Platinum Series Headpiece Model Number AB-7300. The headpiece is used in conjunction with speech pr... 2 Feb-03-2009 Advanced Bionics LLC Mistuned headpiece - Advanced Bionics recently became aware of a tuning issue with some Platinum Series and S-Series headpieces shipped from May 2007 through April 2008. Tuning refers to the process through which the headpiece's communication frequency is adjusted to match that of the internal device. Potential clinical symptoms include: -No lock -Intermittent lock -Implant locks, but can
GSI Audera (version 2.6 software) Viasys Healthcare, Inc. Part or (Catalog) Numbers: 2001-9700, 2... 2 Nov-12-2008 Cardinal Health, Inc GSI Audera systems requires a system software update due to issues with the Split-Screen and the Vestibular Evoked Myogenic Potential (VEMP) functions. A. Split Screen Field Correction: GSI Audera units with version 2.6 software may mislabel Auditory Evoked Potential (AEP) waveform responses with respect to the identification of the stimulus ear.

Additional Information:

[1] National Institution on Deafness and Other Communication Disorders. (2007). Cochlear Implants. Retrieved July 28, 2009. Website:
http://www.nidcd.nih.gov/health/hearing/coch.asp.

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Summary of MedSun Reports Describing Adverse Events With Hot Disposable Packs

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A hot or cold disposable pack is a device intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot or cold therapy for body surfaces. [1]

Over the past 2 years, MedSun has received 12 adverse event reports associated with the hot disposable pack device manufactured by 5 different manufacturers: Hospital Marketing Services Co., Inc. (4), Cardinal Health (4), Kimberly-Clark Corp. (2), Cooper Surgical, Inc. (1), Medline Industries Holdings, L.P. (1). The reports were submitted by 8 hospitals between July 2007 and July 2009.


The reported device problems were :

• Excessive heat produced (4)
• Device burst (4)
• Tape adhered excessively (2)
• Device leakage (1)
• Human factors: did not apply sleeve to pack (1)

No reports involved a patient death. The patient injuries listed below were reported in 11 of these 12 reports.

• Nurse sprayed with contents of pack (4)
• Second degree burn (2)
• Skin tears from tape (2)
• Blisters (2)
• Unspecified level burn (1)

Of the reports that listed patient age, none had a patient age listed as less than 21 years and 9 had a patient age listed as greater than 21 years. Of the reports that listed patient gender, a total of 6 reports involved female patients and a total of 3 reports involved male patients.

The below MedSun reports contributed to FDA awareness of the device problems.


Adverse Event Reports
DeviceDevice Identifiers (model, catalogue number, lot) Event Description
Hospital Marketing Services Co., Inc/Instant warm pack--large None/V6001-043/6378-2 The patient was a difficult IV start. Staff applied two warm packs, both with sleeves, to the patient's bilateral forearms. This was done in an attempt to enhance vasodilation & facilitate ease of IV insertion. The patient complained that the sites were warm and beginning to hurt. When the packs were removed, a fluid filled blister measuring 2cm x 2cm was noted on the left posterior forearm and another fluid filled blister measuring 1cm long x 0.5cm wide was on the right posterior forearm. The RN notified the physician. Both sites were cleaned and dressed with a dressing. There were no changes to the patient's plan of care. An IV was started in another location.
Hospital Marketing Services Co, Inc./ Instant Warm Pack None/V6001-047/None A heat pack was applied, while in an appropriate sleeve, to the patient's neck for neck discomfort. Approximately 2.5 hours later, the patient rang out for the nurse to report a blister on her neck.
Hospital Marketing Sercies,Co., Inc/Instant Warm Pack None/V6001-047/None Patient had first degree burns on abdomen. Apparantly this was from a heat pack on the day of discharge. Six days later the patient was noted to have second degree burns to their abdomen (with eschar). Oral antibiotics were started and silvadene cream and clinic appts were initiated.
Hospital Marketing Services Co., Inc/NovaPlus Instant Warm Pack None/V6001-043/None Patient reported to RN that she was burned from the warm pack that was placed on her left arm prior to an IV start. RN noted the area was red with slight elevation, but no blistering. Patient complained of discomfort. MD notified--no change in management plan. No medications required to treat reddened area. RN noted that the warm pack had been applied directly to the skin and that the hot pack cover had not been applied. This heat pack is a relatively new product to our facility. The previous product did not require a cover or sleeve--this new product does. Staff applied the heat pack without the sleeve, although the packaging clearly indicates that a towel or soft cover should be wrapped around the heat pack before application.
Cooper Surgical/Prism Warm Gel Instant Heat Pack None/20420/None The patient was discharged from the hospital via ambulance to a skilled nursing facility. Upon arrival at the SNF, the patient was found to have what appears to be a second degree burn on her left hand, palm, wrist, and between some of her fingers. There also is a burn on the inner aspect of her right wrist. No such assessment findings were present while the patient was at the hospital before she was discharged. The receiving SNF noted that the patient's left lower arm/hand had a Prism heat pack with a gauze roll holding it in place. The patient's husband has retained the device. Per the husband, the heat pack is not broken and is not leaking.
Medline Industries, Inc./ Accu-Therm None/MDS138005/8079 We have had reports of hot/cold packs exploding. People using these packs are usually moving quickly, trying to take care of patients. It doesn't seem that it was an extreme amount of force that was used to cause the pack to burst. Medline is coming in to investigate these reports and is providing me a formal response. There had been reports of the hot pack being too hot and in some cases bursting. This is the pack that burst on an employee. These packs were pulled off our shelves and pulled from stock. The Medline Account Manager was involved the return process. A member intake specialist at Urgency Care had an instant ice pack explode upon activation.
Cardinal Health/Jack Frost None/30104/V8E135 Staff RN was preparing an Instant Insulated Hot Pack for use on the patient. Following the package instructions the nurse squeezed the package and the package exploded through the top seal and sprayed the nurse in the face and upper body with the liquid contents of the heat pack.
Cardinal Health/Instant Hot Pack Medium None/11450-040/V8E041 When opening a heat pack the heat pack burst open sending it's contents all over the RN, Pyxis and floor.
Cardinal Health Medical Products and Services/Instant Cold Pack, Large None/11440-012/V7H101 The Instant Cold Pack was activated per instructions on package. The staff member felt liquid on her left hand. There was a small amount of clear fluid on the back of her hand. It appeared the package was seeping liquid from a corner. Package design requires pressure on each side, which "pops", then the chemical reaction becomes cold. A few months ago, the same thing happened when another staff member was activating a different cold pack. The remaining packs from that lot number were pulled, and the problem was reported to the regional risk office. Manufacturer response for Chemical Ice Pack, Instant Cold Pack, Large. The sales representitive came and evaluated the device. He then said he was going to take the information back to his quality department for evaluation. We have not received any work of the testing.
Cardinal Health Medical Products and Services/None None/11450-040/None While starting an IV, RN squeezed a hot pack, which exploded onto side of RN's face and upper body. Contents became warm but did not burn. RN showered, and sustained no injury.
Kimberly-Clark Corporation/ Energy Transfer Pad None/None/392105 Kimberly Clark warming pads used on patient during surgery. Side tapes (on pad) were removed gently from the patient's sides. There was redness and weeping on both sides where the tape had been. Nursing informed of injury. Per medical record, stage II skin tears to chest laterally (auxiliary to hips).
Kimberly-Clark Corporation/Energy Transfer Pad None/00315-05Z/386232 A 10 cm X 1 cm red mark, skin tear to left lateral chest involving Kimberly Clark disposable warming pads.

Additional Information:

[1] Food and Drug Administration. (2008). Code of Federal Regulations Title 21.Retrieved July 28, 2009. Website:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?FR=890.5710

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Updated January 1, 2010

Return to MedSun: Medical Product Safety Network

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