RM Global Health

www.rmgh.net

 
  • Increase font size
  • Default font size
  • Decrease font size
  • default color
  • green color
  • blue color

Baxter Healthcare Corp. and FDA notified healthcare professionals

Saturday, 18 August 2007 19:05 Ramaz Mitaishvili
E-mail Print PDF
{mosimage}FDA - MedWatch - Baxter Healthcare Corp. and FDA notified healthcare professionals and consumers of a Class I Recall of Baxter Upgraded COLLEAGUE Triple Channel Volumetric Infusion Pumps, Model numbers 2M8153, 2M8163, and 2M9163.
MedWatch - The FDA Safety Information and Adverse Event Reporting Program

These electronic infusion pumps are used to deliver controlled amounts of medications or other fluids to patients through an intravenous (IV), intra-arterial (IA), epidural, or other direct line into the bloodstream.

The product was 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. This occurs during user programming with all three channels infusing fluids at the same time. There are reports of serious injuries that are associated with this issue. In reported cases, the 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. Remove all the affected triple channel pumps from service immediately.

COLLEAGUE customers with questions should contact Baxter Medical >Delivery Services at 1-800-843-7867.
Last Updated ( Monday, 11 February 2008 19:56 )  
Flu Terms DefinedSeasonal (or common) flu is a respiratory illness that can be transmitted person to person. Most people have some immunity, and a vaccine is available.
Avian (or bird) flu (AI) is caused by influenza viruses that occur naturally among wild birds. Low pathogenic AI is common in birds and causes few problems. Highly pathogenic H5N1 is deadly to domestic fowl, can be transmitted from birds to humans, and is deadly to humans. There is virtually no human immunity and human vaccine availability is very limited.
Flu Terms Defined
Pandemic flu is virulent human flu that causes a global outbreak, or pandemic, of serious illness. Because there is little natural immunity, the disease can spread easily from person to person. Currently, there is no pandemic flu.

Alerts

Can Pharmacists Improve the Accuracy of Medication Histories? Can Pharmacists Improve the Accuracy of Medication Histories? Reviewed by Ramaz Mitaishvili, MD 
 
Byetta Linked to Acute Pancreatitis Six new cases of hemorrhagic or necrotizing pancreatitis have been reported in patients using exenatide injection (Byett...
 
Why Should I Report an Adverse Drug Event? When I was in charge of the postmarketing drug safety program at the US Food and Drug Administration (FDA) in the early ...