Events

Recall of Device Recall Colleague 3 and Colleague 3 CX Volumetric Infusion Pumps

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Baxter Healthcare Corp..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    34096
  • Event Risk Class
    Class 1
  • Event Number
    Z-0445-06
  • Event Initiated Date
    2005-12-13
  • Event Date Posted
    2006-01-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-11-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43107
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Infusion Pumps - Product Code FRN
  • Reason
    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
    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.

Device

Device Recall Colleague 3 and Colleague 3 CX Volumetric Infusion Pumps
  • Model / Serial
    all serial numbers
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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, Belgium, El Salvador, Guatemala, Honduras, Israel, Lebanon, Panama, the Philippines and the United Arab Emirates.
  • Product Description
    Baxter Colleague Triple Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A., Made in Singapore; product codes 2M8153, 2M8153R, BRM8153(Brazilian Portugese), DNM8153(French), HNM8153(German), PNM8153(Spanish), CNM8153(Swedish), GNM8153(Danish), TRM8153(Turkish), WNM8153(Dutch) ,2M8163, 2M8163R
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

Baxter Healthcare Corp.
  • Manufacturer Address
    Baxter Healthcare Corp., Rt. 120 & Wilson Rd, Round Lake IL 60073
  • Source
    USFDA