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
Leave a Reply