—#37981

Product

Baxter Colleague Triple Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, I.V. Systems Division, Deerfield, IL 60015 U.S.A., Made in Singapore; 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: all serial numbers

Why it was recalled

The pumps may experience inadvertent power off, external communications port failures and electronic pump failure codes 402, 403, 533, 535, 599, 810:04 and 810:11.

Root cause (FDA determination)

Device Design

Action the firm took

Baxter sent the 3/15/05 Urgent Device Correction letter to all Colleague Infusion Pump customers to alert them of actions they can take in the short-term to address specific user actions and several error codes in the event of an occurrence, which could lead to serious adverse health consequences if a patient is receiving life-sustaining medication at the time of the pump failure. Users were urged to verify that the pump is infusing after pressing the Start key. If the hospital uses the external monitoring capabilities of the pump for a nurse call or remote pump monitoring, they were requested to ensure that the external computer or monitoring system does not send data to the pump, and that the pump is powered off when connecting and disconnecting the cable to the DB9 port to avoid a 16:336 failure code. If a 16:336 failure occurs the user is advised to power the pump off and back on again. The users were advised to have a contigency plan to mitigate any disruptions of infusions of life sustaining drugs if failure codes beginning with 402, 403, 533, 535 and 599 occur, and to take the pump out of service for inspection by authorized service personnel. The users were also advised to avoid getting fluid on the tubing set or in the pump channel to lessen the occurence of the 810:04 and 810:11 failure codes. If those code failures occur, the pump should be taken out of service for inspection by authorized service personnel. The users were informed that software upgrades are being developed to correct the inadvertent power off problem and to mitigate failure code 16:336 occurrences. 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: 2005-03-15
Posted by FDA: 2005-07-21
Terminated: 2011-06-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #37981. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.