MedSun Annual Report: November 2005 through January 2007
MedSun: Newsletter #17, September 2007

Below you will find the MedSun Annual Report which highlights MedSun accomplishments and activities from November 2005 through January 2007. Report is organized by:
•MedSun Initiated Recalls November 2005 - January 2007
•MedSun Successes – Manufacturers in Action! (organized by device specialty)
•FDA Center for Devices and Radiological Health (CDRH) Teams Based on MedSun Reports
•Surveys/Interviews
•Interviews & Site Visits
•Safety Tips & Articles
•Site Visits to MedSun Hospitals

MedSun Initiated Recalls November 2005 - January 2007

Device: Vapotherm Respiratory Gas Humidifier, Model 2000i
Date Posted: January 19, 2006
Manufacturer: Vapotherm, Inc.
Recall Number: Z-0360-06
Code Information: All S/Ns of the Vapotherm Model 2000i are affected.
Reason for Recall: Instructions for cleaning and disinfection not adequate to prevent infections.


Device: QUIK-COMBO pacing/defibrillation/ECG (therapy) cables used with the LIFEPAK 12 defibrillator/monitor series.
Date Posted: November 02, 2005
Manufacturer: Medtronic Emergency Response Systems, Inc.
Recall Number: Z-0116-06
Code Information: Cables do not contain serial numbers. Therapy cable part number: 3006570-006 and below
Reason for Recall: Potential for voltage pins in connector of therapy cable to break.


Device: Gambro Prisma® Continuous Renal Replacement System
Date Posted: Initiated August, 2005
Manufacturer: Gambro Renal Products, Inc.
Recall Number: NA
Code Information: Model/Catalog Numbers: 018080100, 018080101, 018080001D. All serial numbers
Reason for Recall: Critically ill patients receiving continuous renal replacement therapy may suffer excessive fluid loss if caregivers override the device’s “Incorrect Weight Change Detected” alarm. These alarms alert caregivers to a potential fluid imbalance in the patient. If the cause of the alarm is not addressed, an excessive amount of fluid can be removed from or administered to the patient.


Device: Gambro Prisma M100 preset
Date Posted: April 05, 2006
Manufacturer: Gambro Renal Products, Inc.
Recall Number: Z-0705-06
Code Information: Lot numbers 04K2692P, 05A0754P, 05D1571, 05F0763A, 05F0865, 05F0966, 05F1573G, 05F1574, 05F1675G, 05F2387G, 05F3098G, 05G0556G, 05G0760G, 05G1366G
Reason for Recall: After dialysis machine is disconnected from the patient, blood leakage may occur while unloading the tubing sets from the machine.


Device: Gambro Prismaflex Hemodialysis Machine
Date Posted: October 12, 2006
Manufacturer: Gambro Renal Products, Inc.
Recall Number: Z-0032-2007
Code Information: Catalogue Number 6023014700 Serial numbers: PA0101 to PA0681
Reason for Recall: A potential risk of infusing air or infusion fluid to the patient during dialysis. Also, a possibility of an incorrect scale reading of the amount of patient fluid removal.


Device: Fisher & Paykel IW930 CosyCot Infant Radiant Warmer (with integrat¬ed bed) fitted with 9001W005J Elevator Module
Date Posted: January 11, 2007
Manufacturer: Fisher & Paykel Healthcare Ltd.
Recall Number: Z-0485-2007
Code Information: Various lot numbers
Reason for Recall: This firm has received Product Complaint Reports concerning bending of the pivot plate. The elevator base of the CosyCot Infant Warmer incorporates a pivot plate which forms part of the mechanism allowing the CosyCot to raise and lower in height. A bent pivot plate generally results in the Warmer being unable to elevate properly. Other component failures may result.


Device: Venoscope Neonatal Transilluminator
Date Posted: October 28, 2006
Manufacturer: Venoscope LLC
Recall Number: Z-0116-2007
Code Information: Model NT01
Reason for Recall: Excessive heating due to incorrect wire assembly process.


Device: Hospira brand Plum A+I.V. Infusion Pump
Date Posted: January 12, 2006
Manufacturer: Hospira Inc
Recall Number: Z-0389-06
Code Information: Various serial numbers
Reason for Recall: The pump may shut-off prematurely during battery operation without providing adequate response time when ‘E320’ service warning message appears.


Device: Maquet Ventilator System SERVO-I V3.1 PC1777
Date Posted: February 9, 2007
Manufacturer: Maquet Inc.
Recall Number: Z-0372-2007
Code Information: Article # 64-87-800 Serial # 02400-03300
Reason for Recall: Reported failures of the SERVO-I ventilators user interface system causing technical errors and increased fault frequencies. Switches may be activated unintentionally, or a function not activate when the switch is selected. Direct access knobs may not function or change the parameter in the wrong direction compared to how they are turned.


Device: Convertors Cardiovascular Split Pack II
Date Posted: October 21, 2006
Manufacturer: Cardinal Health
Recall Number: Z-0059-2007
Code Information: Catalog #29158: lot numbers 06FAD300, 06FDA304, 06FAD378, 06FAD386, 06HAD299, 06HAD462, 06HAD485
Reason for Recall: The cardiovascular drape may tear and fray at the reinforced fenestrated trough area during use.
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MedSun Successes – Manufacturers in Action!

Manufacturers have addressed these following issues by: retraining of manufacturing staff; taking corrective actions; issuing Dear Doctor letters to customers; improving labeling, changing suppliers to obtain parts; making current and future design improvements, etc. These have been very conservatively selected – i.e. the manufacturers have told FDA that actions were taken in response to MedSun reports. There are hundreds of other actions that have occurred because the MedSun report added to the trending the manufacturers do – and the manufacturers have taken action on those issues when the problem seems to be occurring higher than the expected rate.

**Please note that the specific manufacturer name is not listed below, and that, in most cases, the action taken is not listed. This data is provided to demonstrate the incredible breadth and scope of the improvement in patient safety that has occurred because of the power of one MedSun report! Where we know that the manufacturer made the action public, we have included it.

CARDIOVASCULAR
•Holter Monitor Analysis System: A holter monitor analysis system waveforms are displayed correctly, but on the printed analysis report form, from which a diagnosis is made, the waveforms are compressed to the point of eliminating the p-wave of the waveform. The p-wave is vital for diagnosing atrio-ventricular block.

•Portable Monitor: A loss of waveform resulted in a drop in the patient’s oxygen saturation for almost one minute. The firm indicates it is notifying consignees of the availability of a new upgraded software version that eliminates the failure mode experienced by the reporting facility.

•Compression Sleeve Connection: There was difficulty in connecting and disconnecting the male and female connectors on a sequential device compression sleeve. In addition, the conductor sometimes pulls completely away from the tubing leaving an open useless hose.
Extracorporeal Membrane Oxygenation (ECMO) Oxygenator: A small amount of blood was noted at the base of an oxygenator and under the outer wrapper. The event occurred during patient transport to the facility. User facility states the device age is one day.

•Warming and Cooling Blankets: Two blankets from the same lot experienced holes and leaks. One was warming and the other one was cooling.

•Pacemaker: manufacturer company representative brought a pacemaker to a surgeon for implantation—it was implanted, and later it was discovered that the device had been recalled many months earlier.

EAR, NOSE, AND THROAT
•Cochlear Implant: Manufacturer failed to inform hospital that a cochlear implant was under recall. The implant was on the hospital shelf, and implanted into a patient.

GASTROINTESTINAL (GI & GU)
•Enteral Polyurethane Feeding Tube: The user facility recently began using this device when the staff noticed a crack at the hub of the device. The crack caused a leak and required early replacement of the tube.

GENERAL HOSPITAL
•Powered Automatic Beds: A safety concern was reported regarding the labeling and readability of the warning for the accessory electrical outlets on two bed models.

•Blood Filters: Numerous MedSun reports cite problems with Rapid Flow Reduction Filters. The filters leaked, even after a previous “fix” that had been instituted.
Blood/Fluid Warmer: A Fluid Warmer was smoking and starting to catch fire.

•Introducers: peel-away introducer sheath did not peel away properly and the physician spent a long time hand-cutting the sheath to get it out of the patient’s body.

•IV Catheter: The hub of a peripheral IV began to leak around the hub end where the catheter emerges.

•IV Catheter: An angio-catheter leaked at the connection of the angio-hub with the catheter.

•Central Venous Catheter Kit: During a central venous catheter insertion, while aspirating, air entered the syringe. A crack was noted in the hub of the needle. Another kit was obtained and an examination of the unused needle from the kit also showed a crack in the needle hub.

•Neonatal PICC Catheter: A minor injury was experienced by a critically ill NICU patient when their dual lumen PICC catheter was noted to be leaking and required immediate removal and replacement. The investigation concluded that the source of the leak was use error and the sales force is re-enforcing the instructions for use (IFU) with their customers.

•IV Set: The check valve on the primary tubing set did not prevent backflow of the secondary fluids into the primary bag.

•IV tubing: An in-line check valve failed to prevent backflow while in use.

•IV Tubing: IV tubing was coming apart at the ‘Y’ of the adaptor.

•IV Tubing: After an IV bag was spiked with the tubing, the tubing would not allow the IV pump to function.

•Needle-Free Injection Site IV tubing: Patient medication was not being infused into the patient and appeared to backflow into the primary IV bag. The firm reemphasized to their customers the importance of fully priming the secondary sets to remove any air from the line, including “tapping” the back-check valve and other components to remove any trapped air, (as stated in the “Instructions for Use”). In addition, the firm stressed the importance of ensuring the primary container is lowered a minimum of 8” when running a secondary infusion.

•Intravascular Administration Set: When opening a disposable IV Fluid Administration Set, the luer lock connection was found to be opened up, when they are normally received connected and tight. The sterility of this product was questioned by the staff.

•Syringe Pump: All infusion pumps from a manufacturer ‘froze up’ at the same time and would not permit any programming to occur. Preventive Maintenance dates for all the pumps were set for a given date by hospital personnel during the initial incoming inspection, one year prior. At or about midnight of that set date, any pump that was turned on would instantly alarm and lockup. The syringe pumps then defaulted to a screen that announced a system failure and then to a screen that displayed “1 Biomed”. If the pump was infusing at midnight, it would continue until complete. However, if an attempt were made to use the pump again, the alarm/lockup would occur. It was determined that the site had programmed the pumps to issue a reminder to users when the preventative maintenance for the pumps was to take place. The software stopped the functioning of the pumps instead of sending the reminder. The manufacturer has sent a letter to customers about this problem.

•Infusion Pump: The pump’s tubing was leaking at the cassette alignment magnet pins.

•Infusion Pump: An over-infusion with the pump is associated with a patient death.

•Infusion Pump: 15cc of air was noted in the lipid syringe and halfway down the tubing of an infant‘s IV Lipids. The lipids had infused too fast and the facility’s clinical engineering department found that the syringe had a dent/defect in it.

•Pain Pump: Pain Pump would not run. There was no direct impact on the patient other than a delay in treatment and increased surgical time.

GENERAL SURGERY
•Malleable retractor: During a valve replacement surgery, the cable on the malleable retractor broke and some of the articulating links fell into the surgical openings in the patient’s chest. The manufacturer sent a memorandum to the reporting customer to remind them of the use, care, and inspection of the device as described in the Instructions for Use. Additional training was also conducted with the sales force to reinforce that the sales reps need to teach physicians proper device inspection.

•Preperitoneal Distension Balloon (PDB) System: The balloon separated from the PDB System while in the patient. The balloon was retrieved and another device was used successfully.

•Steam Integrator: report stated that 6 of 1243 Steam Integrators leaked, thereby spreading ink over the inside of the sterilization pouches and onto the instruments.

IN-VITRO DIAGNOSTICS
•Specimen collection kit for stool Ova Parasites: A non-English speaking patient who was left with a test kit containing two vials of chemical preservative, awaiting stool sample. The patient ingested the contents of vials, one containing polyvinyl chloride and mercuric chloride, and the second vial containing formaldehyde. Many labeling concerns were noted.

NEUROLOGY
•EEG Amplifier: A CTE amplifier was producing mirror imaging of the electroencephalographic signals during monitoring of three patients, resulting in erroneous interpretations of the data.

OBSTETRICS & GYNECOLOGY
•Labor & Delivery Bed: It was noted that the stirrups on a labor and delivery bed fail and allegedly they are easy to move out of position. The reporting MedSun site is currently participating in some customer preference testing. Upon completion of the final validation and verification, the re-designed calf supports will be made available for purchase.

•Vacuum Delivery System: Over the course of a month, problems were noted with 3 separate lots of the vacuums. The fetal extractors were not producing suction and the devices were broken in the package.

RADIOLOGY
•Radiology Table: A technician did not remove the detector plate from under the patient prior to moving the mobile x-ray system away from the bedside. As a result, the patient fell 2-3 feet and landed on the lamb’s wool cover and x-ray detector plate.

•Linear Accelerator: A fiberglass cover fell from a linear accelerator. It landed close to but fortunately did not hit a patient or a health care provider.
Respiratory/Anesthesia

•Adult Respiratory Ventilator Circuit—Dual Heated: Various problems of excessive heating were reported concerning a Dual Heated Adult Respiratory ventilator circuit.

•Ventilator: Excessive corrosion was found on the negative terminal of the main power supply batteries after a burning smell was noted with the device during an operational test. The hospital had notified the firm of this finding and the hospital was provided with a June 2004 Technical Service Bulletin identifying certain batteries that may leak a small amount of acid and corrode the terminals of certain model ventilators. The firm has also issued another Technical Service Bulletin to ensure the replacement of affected batteries and DC modules worldwide.

•Ventilator: Incorrect tidal volume readings.
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FDA Center for Devices and Radiological Health (CDRH) Teams Based on MedSun Reports

External Defibrillators
MedSun received reports describing malfunctions with External Defibrillators (EDs) involving failures of the connecting cables and connectors with “hands-free” configurations. These failures were not discovered during routine functional testing but only when an attempt was made to use them on a patient. A CDRH-cross Center team was organized to evaluate the reported failures. Additional follow-up was made with four of the user facilities that had reported failures via telephone interviews as well as a thorough review of device labeling from various manufacturers. A Safety Tip was prepared entitled, “External Defibrillators Fail to Shock: Means for helping to prevent defibrillator cable and connector malfunctions”.

Bioglue
MedSun reports describe ten pediatric neurosurgical cases where the use of Bioglue® Surgical Adhesive resulted in serious patient outcomes. Bioglue® is a surgical adhesive indicated for use as an adjunct to standard methods of achieving hemostasis in adult patients undergoing open surgical repair of large vessels. It is not expected to be reabsorbed by the body since one of its roles is to strengthen the target tissue. A CDRH-cross Center team was created. The team developed a questionnaire to more fully understand the neurologists’ level of knowledge and experiences with the use of Bioglue and like products. Three neurologists from MedSun sites agreed to answer the questionnaire during telephone interviews. In the meantime, Health Canada has issued a warning that use in neurosurgery can result in adverse events. Two employees from Health Canada are now on the team. The team continues to meet to develop Center-wide solution strategies to these problems.

Electric Hand piece Burns
A MedSun report describes a scenario in which an electric hand piece was being used during a dental procedure, resulting in a patient being severely burned on the upper lip. A review of all adverse event reports in the Center database, a review of the medical literature, and a discussion with FDA scientific reviewers all suggest that electric hand pieces pose a greater risk for burns than traditional air-driven hand pieces. An article about this issue was written and submitted to the Dental Association newsletter. Additionally, a Center team is evaluating solution strategies to the problem.

Implantable Pain Pump Programmer
A MedSun report describes a serious overdose incident. Follow-up revealed that the issue happened when a “bridge bolus” was not properly programmed into the pain pump and that the user may have ignored the pump’s warnings. Discussion with the MedSun site indicated possible Human Factor problems with the screens on the programmer. A CDRH-cross Center team was brought together to evaluate the issue. In addition, the manufacturer provided a demonstration to CDRH on the use of the device in question. The team also visited National Rehabilitation Center for a clinician’s demonstration and a re-creation of the “bridge bolus” incident. The manufacturer met with CDRH in early February 2007 to discuss solutions proposed for the bridge bolus functions. The manufacturer presented at the 2007 Conference for MedSun Representatives about its approach to solving Human Factor issues and about this problem in particular.

Monitor/oximeter and EMI Interference
A MedSun report describes a possible EMI interaction problem with a monitor/oximeter and the hospital’s fire alarms. Follow-up of this event includes posting on DS-X to ascertain if this type of event has occurred in other facilities. Follow-up with the user facility resulted in a request for a MedSun/ECRI visit to the hospital (upon the hospital’s invitation for a 3rd party to visit and evaluate the problem on-site). CDRH’s EMI experts are participating in the MedSun team’s on-going discussions.

Reprocessing of Orthopedic Instruments
MedSun has received several reports indicating problems with accessibility of cleaning, disassembly, and sterilization instructions for orthopedic instruments. There have been reports of instances when instructions for reprocessing orthopedic instruments are not available to the hospitals. A team was assembled to gather detailed information. The team has interviewed several MedSun facilities for their experiences with reprocessing orthopedic instruments. The team is exploring strategies to address the issue.

Transilluminator
Venoscope Transilluminator Recall, which occurred because a MedSun site reported that a neonate was burned by the device. Additionally, the site also tested several other transilluminators and found that the temperatures varied. MedSun has established a team to evaluate the issue, which will include conducting bench testing on various manufacturers’ transillumination devices to determine temperature outputs as well as visual light emissions. Depending on the findings, future regulatory action may be taken.

Human Factors Workgroup
A Center-Wide team has been established to evaluate and implement strategies to ensure the use of Human Factor principles throughout the Total Lifecycle of Medical Devices.
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Surveys/Interviews

Enteral Feeding Connector (Luer Lock)
The Luer Lock group at the FDA is interested in evaluating the types of connectors used for enteral feeding, including those used in conjunction with nasogastric tubes, gastrostomy tubes, and jejunostomy tubes. Email invitations were sent to 150 Lead Representatives at MedSun hospital sites on July 12, 2006. The majority were completed via a secure web-based survey site managed by SSS. Follow up calls and emails were sent to stimulate more responses. This survey was completed in October 2006.
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Interviews & Site Visits

PRISMA Continuous Renal Replacement Device:
MedSun hospitals helped FDA determine the impact and results of the intermediate actions taken by GAMBRO to address problems with its devices until software changes could be developed. GAMBRO developed additional user training and red stickers to be placed on the devices reminding users not to press the ‘continue’ button after an alarm occurs unless the reason for the alarm had been identified and resolved. A total of six interviews were held with MedSun sites, which indicated that GAMBRO had fulfilled the intermediate steps. Additionally, several MedSun sites in the DC area permitted an FDA analyst to observe the device. GAMBRO is installing the newly developed software into customers’ devices. Please continue to report any problems with this device, so FDA may monitor the effectiveness of the software changes.

BAXTER Colleague Volumetric Pumps:
Four MedSun sites were contacted to discuss the impact of potential actions and implications of future steps with regard to reported problems with the Baxter Colleague pumps and the Baxter Syndeo PCA Syringe pumps. The information was very helpful in determining the least burdensome regulatory approach.
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Safety Tips & Articles

•"Pneumatic Tourniquet and Tourniquet Systems."
•"Systems Failures” (displayed in a Swiss Cheese Model, based on a sequence of events, resulting in patient harm with a diagnostic laboratory device).
•"Preventing PICC fractures."
•"Cables and Electrodes Can Burn Patients During MRI."
•"External Defibrillators Fail to Shock: Means for helping to prevent defibrillator cable and connector malfunctions."
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Site Visits to MedSun Hospitals:

•Implantable Pain Pump Demonstration
•Venoscope Transilluminator Demonstration
•HeartNet Interviews and Observations of EP Labs
•Radiology/CT site visit
•Radiology site visit and Operating Room Table Demonstration
•Demonstration of robot-assisted surgical device.
•Observation and discussion of extracorporeal membrane oxygenator equipment in clinical use.
•Observation and discussion about wireless infusion therapy device systems.


MedSun Newsletters are available at www.fda.gov/cdrh/medsun