Recall Z-0345-05 ยท FRN Pump, Infusion
Baxter Healthcare Corp.
Colleague 3 CX Triple Channel Volumetric Infusion Pumps, product code 2M8163 and 2M8163R; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in Singapore; color display screen
| Date | Dec 22, 2004 (initiated Nov 4, 2004) |
| Status | Terminated |
| Reason | A software anomaly causes a failure alarm code 12:303 which audibly alarms and stops the function of all channels in use. This causes an interruption in therapy, which may result in a risk to the patient. |
| Root cause | Other |
| Action | Baxter sent Urgent Device Correction letters dated 11/4/04 to the direct accounts to the attention of the Director of Biomedical Engineering on the same date. The letters informed the accounts of the 12:303 failure and possible interruption of patient therapy when it occurs. They were informed that new software was available to address the failure alarm code with the infusion pumps, and that the software also included updates to the predefined label library and the addition of a text message 'Close regulating roller clamp' to the manual tube release pop-up message. The software is being insta |
| Distribution | Nationwide and internationally to Australia, the Bahamas, Belgium, Brazil, Canada, Colombia, El Salvador, Guatemala, Honduras, Israel, Lebanon, Mexico, New Zealand, Panama, the Philippines, Saudi Arabia, South Africa, Taiwan, Turkey, United Arab Emirates and the United Kingdom. |
| FDA record | Open on fda.gov |