—#38000

Product

Baxter Colleague Triple Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, I.V. Systems Division, product codes 2M8153, 2M8153R, 2M8163, 2M8163R

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K041191
Affected lot / code info: product codes 2M8153 and 2M8153R: all serial numbers below 13120001CT; product codes 2M8163 and 2M8163R: all serial numbers below 13110338TC

Why it was recalled

Swelling of the sealed lead-acid batteries in the infusion pump can cause internal pump damage, and excessive battery discharge can damage the batteries if the pump is left on battery power for an extended period of time after teh Battery Depleted alarm occurs.

Root cause (FDA determination)

Labeling design

Action the firm took

Baxter sent letters dated 02/25/05 to all Colleague infusion pump customers to provide them with important supplemental information to the letter dated 1/21/03 (Z-929-1), regarding sealed lead-acid batteries used in the Colleague family of infusion pumps, dealing with swollen batteries and excessive deep discharge. The 2/25/05 letter reiterated the battery service life, replacement and pump storage conditions which were listed in the 1/21/03 letter, and informed the users that current production pumps have an overcurrent protection circuit in the battery harness to help protect the batteries from overcurrent damage and swelling during charging, and advised them of the availability of the battery harness. The letters also provided information to prevent excessive discharge, and advised them that software updates will become available later in 2005. An Operator's Manual Addendum was also included with the 2/25/05 letter, replacing chapter 7 of the manual dealing with Maintenance and Service. Any questions were directed to Baxter's Medication Delivery Services at 1-800-843-7867.

Recalling firm

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

Distribution

Distribution pattern: Nationwide including Puerto Rico, and internationally to Taiwan, Canada, Chile, Korea, Colombia, New Zealand, China, Hong Kong, Brazil, Turkey and Saudi Arabia.

Timeline

Recall initiated: 2005-02-25
Posted by FDA: 2005-09-23
Terminated: 2011-02-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #38000. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.