Source | FDA

Baxter Provides Update on Service Documentation Class I Recall

Models Include: COLLEAGUE Mono Volumetric Infusion pump, Product Codes 2M8151 and 2M8153; COLLEAGUE CX Volumetric Infusion pump, Product Codes 2M8161 and 2M8163; FLO-GARD 6201 Volumetric Infusion pump, Product Code 2M8063; and FLO-GARD 6301 Volumetric Infusion pump, Product Code 2M8064

FOR IMMEDIATE RELEASE — Baxter Healthcare Corporation today 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.

As announced on July 25, 2007, in the course of its ongoing quality control processes, the company discovered falsified service documentation data. Therefore, it is possible that pumps sent to be serviced, repaired or corrected were returned without service being performed on them. Previously, the recall pertained to 534 infusion pump devices serviced in the company’s Phoenix, Arizona service center. The expansion of the recall represents pumps serviced by all three employees previously mentioned who have been dismissed. Baxter’s investigation of the matter is continuing. The company will continue to provide updates and instructions to users regarding the service documentation recall on www.baxter.com.

The company has informed all customers to contact Baxter and return affected pumps for repeat inspection and servicing and will provide loaner pumps free of charge. There are no serious injuries or patient deaths associated with this action to date. This recall action impacts only pumps distributed in the United States.

This issue was classified by FDA as a Class I recall on July 24, 2007, because of the potential risk of serious injury or patient death if affected devices malfunction. A defect 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. Affected model numbers include: FLO-GARD Model Numbers 6201 and 6301 Volumetric Infusion pump, Product Codes: 2M8063 and 2M8064; COLLEAGUE Volumetric Infusion pump, Product Codes: 2M8151 and 2M8153; and COLLEAGUE CX Volumetric Infusion pump, Product Codes: 2M8161 and 2M8163. The Agency is expected to issue a Preliminary Public Health Notification on Baxter’s service documentation recall.

Source | Baxter Healthcare Corp.

Models Include: COLLEAGUE Volumetric Infusion pump 2M8151 and 2M8153; COLLEAGUE CX Volumetric Infusion pump 2M8161 and 2M8163;  FLO-GARD Volumetric Infusion pump 2M8063 and 2M8064

DEERFIELD, Ill., July 25, 2007 – Baxter Healthcare Corporation today announced that the U.S. Food and Drug Administration (FDA) has classified Baxter’s voluntary recall action regarding falsification of service and repair data for the COLLEAGUE and FLO-GARD infusion pumps as a Class I recall. The recall pertained to 534 infusion pump devices in the U.S. brought in for routine maintenance or corrections at the company’s Phoenix, Arizona service center.

“In the course of its ongoing quality control processes, the company discovered falsified repair, test and inspection data sheets, which included electrical safety data.”

Therefore, it is possible that pumps sent to be serviced, repaired or corrected were returned without service being performed on them. Three employees in the Phoenix service center associated with this matter have been dismissed. The company has recalled affected devices and has informed all customers to contact Baxter and return the pumps for repeat inspection. All affected customers have been notified and no serious injuries or patient deaths have been associated with this action to date. This recall action impacts only pumps distributed in the United States.

This action has been classified by FDA as a Class I recall because of the potential risk of serious injury or patient death if affected devices malfunction. A defect 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. Affected model numbers include: FLO-GARD Volumetric Infusion pump 2M8063 and 2M8064; COLLEAGUE Volumetric Infusion pump 2M8151 and 2M8153; and COLLEAGUE CX Volumetric Infusion pump 2M8161 and 2M8163.

Source | FDA

Date Recall:  Initiated June 21, 2007
 
Product: Baxter Colleague® and FLO-GARD® Volumetric Infusion Pumps

• COLLEAGUE® Volumetric Infusion Pump (2M8151, 2M8153)
• COLLEAGUE® CX Volumetric Infusion Pump (2M8161, 2M8163)
• FLO-GARD® Volumetric Infusion Pump (2M8063, 2M8064)

From April, 2006 through February, 2007, Baxter distributed 534 pumps to 170 customers (including distributors, medical facilities, retail companies and one institution) within the U.S.

Use: Electronic infusion pumps deliver controlled amounts of medications or other fluids to patients through an intravenous (IV), intra-arterial (IA), epidural, and other acceptable routes of administration.
 
Recalling Firm: Baxter Healthcare Corp., Rt. 120 & Wilson Rd., Round Lake, Illinois 60073 

Reason for Recall: The firm identified repair, inspection & test data sheets, which included electrical safety data, for the pumps, that were falsified.

FDA Comments: On June 21, 2007, Baxter contacted their customers informing them that the company discovered, during ongoing quality control processes, that 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.

The company requested their customers to locate the affected pumps and take them out of service as soon as possible, and send them back to Baxter for repeat inspections and servicing. Baxter will provide loaner pumps to customers that require them, free of charge.

For more information about this recall, please see the company’s press release at:

http://www.baxter.com/about_baxter/news_room/news_releases/2007/07-25-07-service_documentation.html

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 this product to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

See also: June 20, 2007, Recall for Baxter Upgraded COLLEAGUE® Triple Channel Volumetric Infusion Pumps
http://www.fda.gov/cdrh/recalls/recall-062007.html