WARMFLO
Received Mar 5, 2008
Report 2936999-2008-00113 · MDR key 1008269
Device
Generic name
Fluid Warming Cassette
Manufacturer
HenequenModel number
WF-100 CASSETTECatalog number
WF-100
Product problems
- Thermal Decomposition of Device
- Device Emits Odor
Patient
Not reported
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
A WARMFLO WF588 FLUID WARMER AND WARMFLO WF-100 CASSETTE WERE BEING USED DURING A TRANSFUSION. DURING THE PROCEDURE A NURSE NOTICED A BURNING SMELL COMING FROM THE FW588. SHE STOPPED THE PROCEDURE AND EXAMINED THE CASSETTE AND NOTICED THE BLOOD WAS VERY DARK. NO PT INFO WAS PROVIDED.
Additional Manufacturer Narrative
IN THE MORNING AFTER THE EVENT, THE NURSE SENT THE WARMFLOW 588 FLUID WARMER TO THE HEAD OF THE MEDICAL TECH DEPT. HE REPORTED IT WAS THEN OPENED, EXAMINED, AND TESTED AND IT FUNCTIONED PROPERLY. COVIDIEN HAS REQUESTED THE WARMFLO 588 FLUID WARMER, AND THE WARMFLO WF-100 CASSETTE BE RETURNED FOR FAILURE INVESTIGATION, HOWEVER, THE CASSETTE USED WAS SENT TO A LOCAL LAB FOR EVAL. THIS INVESTIGATION IS CURRENTLY IN PROGRESS. WHEN THE RESULTS FROM THE LAB CAN BE REVIEWED BY OUR CLINICAL SPECIALIST, AND/OR ANY NEW SIGNIFICANT INFO IS OBTAINED, A FOLLOW-UP REPORT WILL BE FILED.