Device Recall Colleague 3, 3 CX and 3 CXE Volumetric Infusion Pumps 의 리콜

Recall

38219

Class 1

Z-1091-2007

2007-06-20

2007-07-18

Terminated

United States

2011-12-20

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53170

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.

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.