WARMFLO CASSETTE

Description of Event or Problem

IT WAS REPORTED THAT THE WARMFLO CASSETTE WAS LEAKING FROM THE SYRINGE INJECTION PORT WHERE IT CONNECTS TO THE MAIN TUBING. IT WAS CONNECTED TO A PT AT THE TIME OF THE REPORTED LEAK. THE CASSETTE WAS REMOVED AT THAT POINT.

Additional Manufacturer Narrative

RETURN OF THE WARMFLO CASSETTE FOR FAILURE INVESTIGATION HAS BEEN REQUESTED. THE LOT NUMBER WAS PROVIDED AND THE MFR WILL REVIEW THE LOT HISTORY RECORDS. IF THE CASSETTE IS RETURNED AND FAILURE INVESTIGATION RESULTS PROVIDE SIGNIFICANT INFO, A FOLLOW-UP REPORT WILL BE SUBMITTED. IT WAS ALSO REPORTED THAT AFTER THE CASSETTE WAS REMOVED FROM THE PT, THE HOSP TESTED IT WITH THE FLUID WARMING UNIT SET ON FLOW AND IT DID NOT LEAK FLUID. IT CONTINUOUSLY DREW IN AIR AT THE POINT WHERE THE PREVIOUS LEAK WAS REPORTED, PRODUCING A STREAM OF BUBBLES. IT IS NOT KNOWN IF THE CASSETTE WAS TESTED IN THE SAME FLUID WARMING UNIT USED FOR THE PT, OR IN A DIFFERENT FLUID WARMING UNIT. IT IS NOT KNOWN IF THE CASSETTE WAS PRE-TESTED OR PRIMED BEFORE USE WITH THE PT. NOTE: THE MFR'S DIRECTIONS FOR USE FOR THE WARMFLO CASSETTE STATES UNDER: A. PRIME TO ELIMINATE AIR: CONNECT YOUR PREFERRED FLUID SPIKE SET TO THE FLUID WARMING CASSETTE. CONNECT YOUR PREFERRED PT EXTENSION LINE TO THE FLUID WARMING CASSETTE. SPIKE THE FLUID BAG. HOLD BOTH FLUID BAG AND DRIP CHAMBER UPSIDE DOWN. SQUEEZE THE FLUID BAG TO PUSH AIR FROM THE BAG INTO THE DRIP CHAMBER. CONTINUE TO SQUEEZE UNTIL THE DRIP CHAMBER IS 1/2 FULL OF FLUID. CLOSE THE INDICATED SLIDE CLAMP. TURN THE FLUID BAG RIGHT SIDE UP AND HANG THE BAG FROM EITHER THE INFUSOR DOOR OR FROM THE IV POLE HOOKS. CLOSE THE ROLLER CLAMP. OPEN THE SLIDE CLAMP BELOW THE FLUID BAG. PINCH THE BALL IN THE AIR VENT TUBE. FLUID WILL BEGIN TO FLOW FROM THE FLUID BAG INTO THE FLUID SET. RELEASE THE BALL IN THE AIR VENT TUBE WHEN THE AIR CHAMBER IS FILLED 3/4 WITH FLUID. DO NOT ALLOW FLUID TO RISE INTO THE AIR VENT TUBE. CAUTION: TAP THE FILTER CHAMBER TO RELEASE MICRO BUBBLES FROM FILTER SCREEN. OPEN THE ROLLER CLAMP TO PURGE AIR FROM PT LINE. CLOSE THE ROLLER CLAMP. THE FLUID SET IS NOW PRIMED AND READY FOR USE. REFER TO FLUID WARMER OPERATOR'S MANUAL FOR FURTHER INSTRUCTION. THE MFR'S DIRECTIONS FOR USE FOR THE WARMFLO WF-100 CASSETTE STATES UNDER: WARNINGS AND PRECAUTIONS: ALL AIR MUST BE REMOVED FROM THE FLUID LINES PRIOR TO CONNECTION TO THE PT. MONITOR FLUID LINES THROUGHOUT PROCEDURE TO ENSURE THAT THEY ARE AIR-FREE. CONTINUE TO PURGE AIR FROM AIR CHAMBER. NEVER INFUSE FLUIDS WHEN AIR BUBBLES ARE PRESENT IN THE PT LINE. FAILURE TO REMOVE AIR BUBBLES COULD RESULT IN SERIOUS INJURY OR DEATH.