WARMFLO
Received Feb 22, 2008 · Event occurred Jan 14, 2008
Report 2936999-2008-00071 · MDR key 1001206
Device
Product problems
- Difficult to Insert
- Replace
- Device, removal of (non-implant)
Patient
UNK
- Anemia
- Hypothermia
- Tachycardia
Narrative
Description of Event or Problem
COVIDIEN RECEIVED A REPORT THAT A WARMFLO FLUID CASSETTE WOULD NOT INSERT PROPERLY INTO A WARMFLO FLUID WARMER DURING A PROCEDURE. AFTER TWO ATTEMPTS, THE STAFF REMOVED THE CASSETTE AND ADMINISTERED NEW BAGS OF A COLD UNK SOLUTION DIRECT TO THE PT MANUALLY AND THE PT REPORTED TO HAVE TACHYCARDIA AND HYPOTHERMIA. THE FLUID BEING USED WAS REPORTED TO NOT BE BLOOD, BUT SOME OTHER SOLUTION. NO OTHER INFO WAS PROVIDED.
Additional Manufacturer Narrative
COVIDIEN HAS REQUESTED THE RETURN OF THE CASSETTE FOR FAILURE INVESTIGATION. THE LOT NUMBER HAS BEEN PROVIDED AND A REVIEW OF THE LOT HISTORY IS IN PROCESS. A FOLLOW UP REPORT WILL BE SENT WITH THE RESULTS OF THE DEVICE HISTORY REVIEW AND FAILURE INVESTIGATION RESULTS SHOULD THE CASSETTE BE RETURNED.