Two Ventricular Assist Recalls by Thoratec

A ventricular assist device is a mechanical pump that helps a person's heart that is too weak to pump blood through the body.

The Thoratec Corporation of Pleasanton, California has announced Class 1 Recalls of two medical devices today in cooperation with the FDA:

Recall I:
Thoratec Paracorporeal Ventricular Assist System (PVAD)
This P-VAD was recalled because it may contain a black collet (circular rim) that holds a rod-like nut in place, which was intended to be used with a cannula (a small tube) of an older design that had a larger diameter. If this black collet and nut is used with the current design of cannula that has a smaller diameter, it can disconnect during use.

The VAD is designed to provide sufficient blood flow to the damaged or diseased heart, and if it is not working properly the patient could suffer further injury to the heart, or possibly die from lack of blood flow. Thus, it is very important that medical professionals check their PVADs from Thoratec to determine which design is being used. They are advised to dispose of any expired original design cannula. Do not use the black collet and nut with any design VAD. Make sure that all current patients using PVADs are using the white collet nut that is packaged with the cannula. Patients may call Thoratec Corporation at 1-925-847-8600.

Because Thoratec has already alerted hospitals and medical center customers of this 'urgent recall', it is up to the individual doctors to contact their patients.

Recall II:
Thoratec TLC-II Portable Ventricular Assist Device (VAD) Driver

Thoratec TLC-II Portable Ventricular Assist Device (VAD) Driver, Catalog No. 20010-0000-032 has been recalled because the VAD support for the VAD driver may stop due to earlier than expected wear-out of the compressor motor (much less than the expected 3000 hours), causing inadequate blood flow to and from the heart.

The compressor motor can stop without warning! Medical professionals and patients are advised to check the current number of service hours on all units. Do not use the TLC-II drivers exceeding 1500 hours until they are serviced by Thoratec. Ensure that all patients have a back-up driver and hand pumps at all times and have been trained in backup procedures. When the 1500 hour limit has been reached, patients must stop using the device and send it to the manufacturer for servicing. Patients should replace all drivers at 1500 hours and go back to the hospital for a new backup replacement. Patients may call the company at 1-925-847-8600.

Urgent Recall of Baxter Healthcare COLLEAGUE Triple Channel Volumetric Infusion Pumps

UPDATE: On August 7, 2007, Baxter Healthcare Corporation announced an update to the July 25, 2007 Class I recall press release regarding falsified repair, test and inspection data sheets, which included electrical safety data for COLLEAGUE and FLO-GARD infusion pumps. Baxter has expanded the recall to include an additional 986 COLLEAGUE infusion pumps, which need to be returned to the company for repeat inspection, because of falsified electrical safety data. Read more on the FDA press release.

UPDATE: On June 21, 2007, Baxter contacted their customers informing them that some repair, test and inspection data sheets, including electrical safety data, were falsified. As a result, it may be possible that pumps sent to be serviced, repaired, or corrected were returned without service being performed on them. This may result in over infusion, under infusion, failure to detect an upstream or downstream occlusion, electrical shock hazard, failure to detect air in line and malfunctions where the pump will stop infusing and result in an interruption of therapy that can result in death!

Baxter Healthcare and the US Food and Drug Administration (FDA) notified healthcare professionals and consumers Friday of a Class I Recall (the most serious) of Baxter Upgraded COLLEAGUE Triple Channel Volumetric Infusion Pumps, Model numbers 2M8153, 2M8163, and 2M9163.

Doctors, nurses, caregivers and other medical professionals are advised to remove all the recalled triple channel Baxter pumps from service immediately.

Infusion pumps deliver controlled amounts of medications and other fluids to patients through an intravenous (IV), intra-arterial (IA), epidural, or other direct lines into the bloodstream.

The Baxter infusion pumps were recalled because a software irregularity causes the newly upgraded COLLEAGUE Triple Channel Volumetric Infusion Pumps to alarm, display an error code (16:310:867:0002) and stop the infusion. The error occurs during user programming with all three channels infusing fluids at the same time.

There are multiple reports of serious injuries that are associated with this medical device defect. In reported cases, the Baxter infusion pump stopped infusing which caused it to activate an audible and a visual alarm. Interruption of life-sustaining therapy could lead to serious injury or death.

Again, doctors, nurses, caregivers and other medical professionals are advised to remove all the affected triple channel pumps from service immediately. Patients and COLLEAGUE customers with questions should contact Baxter Medical Delivery Services at 1-800-843-7867.

Baxter Healthcare Corp.
Rt. 120 & Wilson Rd.
Round Lake, Illinois 60073

NOTES:

This is not the first time Baxter Healthcare has had to initiate a Class I Recall of COLLEAGUE and COLLEAGUE CX Volumetric Infusion Pumps. See these recalls from 2005.

From June 20, 2007 through June 21, 2007, Baxter telephoned their customers and informed them that Baxter had received multiple reports of newly upgraded COLLEAGUE Triple Channel Infusion Pumps alarming, displaying an error code and stopping infusion.

These reported events occurred during user programming with all three channels infusing fluids at the same time. In all cases, the pump stopped the infusions in all three channels, which caused it to activate an audible and visual alarm.

Baxter requested that all of the affected triple channel pumps be immediately removed from service. These pumps were identified by two attached hangtags entitled "Battery and Power On."

Baxter informed their customers that representatives would be in contact with them to coordinate the replacement of the affected pumps with upgraded single channel pumps or non-upgraded triple channel pumps.

COLLEAGUE® customers with questions may contact Baxter Healthcare's Medical Delivery Services at 1-800-843-7867.

For more information about this medical device recall, please see the Baxter's press release.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of the Baxter Healthcare COLLEAGUE Triple Channel Volumetric Infusion Pumps or any other medical device or pharmaceutical drug to the FDA's MedWatch Adverse Event Reporting program below.

Report Online: www.fda.gov/MedWatch/report.htm

Report by Regular Mail: use postage-paid FDA form 3500.
Mail to:
MedWatch 5600 Fishers Lane
Rockville, MD 20852-9787

Or FAX to: 1-800-FDA-0178