Events

Recall of Device Recall Colleague 3, 3 CX and 3 CXE 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
    38219
  • Event Risk Class
    Class 1
  • Event Number
    Z-1091-2007
  • Event Initiated Date
    2007-06-20
  • Event Date Posted
    2007-07-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53170
  • 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 Pump - Product Code FRN
  • Reason
    A software anomaly is causing newly upgraded colleague triple channel infusion pumps to alarm, display an error code (16:310:867:0002) and stop the infusion. this occurs during user programming with all three channels simultaneously infusing fluids. in reported cases, the pump stopped infusing and both an audible and a visual alarm notification were activated.
  • Action
    Baxter telephoned the direct accounts on 6/20-21/07, informing them that Baxter has received multiple reports of newly upgraded Colleague Triple Channel Infusion Pumps alarming, displaying an error code and stopping infusion. These reported events occurred during user programming with all three channels simultaneously infusing fluids. In all cases, the pump stopped the infusions and both an audible and visual alarm notification were activated. The accounts were requested to immediately remove the affected triple channel pumps, identified by two attached hangtags entitled "Battery" and "Power On", from service. The accounts were informed that their Baxter representative would be in contact with them to coordinate the replacement of the affected pumps with upgraded single channel pumps or non-upgraded triple channel pumps, if available. Any questions were directed to Baxter's Medication Delivery Services at 1-800-843-7867. Baxter sent follow-up Urgent Product Recall letters dated 6/22/07.

Device

Device Recall Colleague 3, 3 CX and 3 CXE Volumetric Infusion Pumps
  • Model / Serial
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Canada, Australia, Belgium, New Zealand, South Africa, Thailand, and Singapore.
  • 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, 2M8163, 2M9163
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

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