WARMFLO

Description of Event or Problem

IN EARLY 2008, COVIDIEN RECEIVED A REPORT THAT A FLUID WARMING CASSETTE BECAME DISCONNECTED AT THE DISTAL END AND THE FLUID BEING USED SPILT ON THE PATIENT. IT WAS REPORTED THE PATIENT BECAME COLD WITH A BODY TEMPERATURE OF 35.3 AND REQUIRED AGGRESSIVE WARMING. THERE WAS NO INFORMATION PROVIDED TO INDICATE IF THE REPORTED TEMPERATURE (35.3) WAS CELSIUS OR FAHRENHEIT.

Additional Manufacturer Narrative

COVIDIEN HAS REQUESTED THE CASSETTE BE RETURNED FOR FAILURE INVESTIGATION. IF THE CASSETTE IS RETURNED FOR A FAILURE INVESTIGATION, AND/OR THERE IS ANY NEW SIGNIFICANT INFORMATION OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.