Baxter Colleague Single Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, Medication Delivery Division,

FDA device recall Z-0444-06 · posted 2006-01-31 · Terminated

Recall details

Recalling firm

Baxter Healthcare Corp.

Reason for recall

Interruption of therapy due to battery undercharging, the generation of air-in-line alarms due to IV administration set tugging, and gearbox wear; and underinfusion due to misalignment of the pump head components.

Action taken

Baxter sent the 12/13/05 Urgent Device Correction letter to all Colleague Infusion Pump customers, to the attention of the Director of Nursing and the Biomedical Engineer, via first class mail to alert them to additional problems with the pump that may interrupt therapy. These issues include battery undercharging, generation of false air detected alarms due to IV administration set tugging, gearbox wear, underinfusion and non-detection of upstream occlusions. The letters included mitigating instructions to reduce the occurrence of these potential problems, and included a copy of the Battery Usage Guide, Infusion Management Guide, and the March 17, 2005 Buretrol Set Urgent Device Correction letter to be provided to all users of the Colleague pump. Baxter informed the accounts that they would be notified when the new release of the Colleague Volumetric Infusion Pump Operator''s Manual is available. Any questions were directed to Baxter''s Medication Delivery Services at 1-800-843-7867.

Root cause

Device Design

Status

Terminated

Product code

FRN

Quantity affected

152,260 pumps

Distribution

Worldwide distribution: USA, Puerto Rico, United Kingdom, Canada, Brazil, Hong Kong, Taiwan, Turkey, Kuwait, South Africa, Chile, Saudi Arabia, Korea, Mexico, Colombia, New Zealand, the Bahamas, Belgi

Date initiated

2005-12-13

Date posted

2006-01-31

Date terminated

2011-11-30

Location

Round Lake, IL

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