ORS-100 FLUID WARMING DRAPE

Additional Manufacturer Narrative

AT THE TIME OF THIS REPORT, THE DEVICE HAD NOT BEEN RETURNED FOR EVALUATION. AS NO DEVICE WAS AVAILABLE FOR EVALUATION, THE ROOT CAUSE OF THIS COMPLAINT CANNOT BE CONFIRMED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

Description of Event or Problem

FLUID WARMER DRAPE WAS PLACED IN BIRD BATH WARMER DEVICE AND SULFAMYLON WITH EPINEPHRINE WAS POURED INTO WARMER. LAP SPONGES WERE PLACED IN THE WARMING BATH DURING THE PROCEDURE. AT THE END OF THE CASE, THE WARMER DRAPE WAS NOTED TO HAVE A HOLE. STAFF DID NOT IDENTIFY ANY CONCERNS WHILE INSTALLING THE DRAPE ON THE FLUID WARMING UNIT. THE SURGEON WAS NOTIFIED AND NO ADDITIONAL ACTIONS WERE TAKEN FOR THE PATIENT (SURGERY WAS A WOUND DEBRIDEMENT). THE DRAPE WAS SAVED TO RETURN TO THE MANUFACTURER AND THE WARMING EQUIPMENT WAS QUARANTINED AND TAKEN TO BIOMED TO TEST TO ENSURE WORKING CORRECTLY. THE UNIT WAS TESTED AND PASSED BIOMED TESTING. STAFF WERE NOT AWARE OF ANY AIRPOCKETS DURING THE PROCEDURE, NO INSTRUMENTS WERE PLACED IN THE WARMER DURING THE CASE THAT WOULD HAVE POSSIBLY PERFORATED THE DRAPE. THE WARMER HAD FLUID IN THE BASIN BEFORE THE UNIT WAS TURNED ON TO HEAT THE SOLUTION AND THE SETTING DURING THE PROCEDURE WAS 105 DEGREES.

Additional Manufacturer Narrative

AT THE TIME OF THIS REPORT, THE DEVICE HAD NOT BEEN RETURNED FOR EVALUATION. AS NO DEVICE WAS AVAILABLE FOR EVALUATION, THE ROOT CAUSE OF THIS COMPLAINT CANNOT BE CONFIRMED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. FOLLOW UP #1. A LOT NUMBER WAS NOT PROVIDED SO A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. A SAMPLE WAS RECEIVED FOR EVALUATION. A SMALL BURN MARK/HOLE FROM THE CENTER OF THE DRAPE WAS OBSERVED. BASED ON THE SAMPLE REVIEW, THIS DOES NOT APPEAR TO BE THE RESULT OF A PERSONNEL, PROCESS OR MATERIAL ISSUE. MELTS, THOUGH UNCOMMON, CAN OCCUR WHEN THE WARMER IS NOT DRAPED PROPERLY, NOT TURNED OFF BY USING THE POWER BUTTON, AND/OR THERE IS INSUFFICIENT FLUID IN THE WARMER BASIN, CONTRARY TO THE OPERATIONS MANUAL, PRODUCT LABELING, PRODUCT INSERT AND IN-SERVICE PRESENTATIONS. BECAUSE THIS APPEARS TO BE RELATED TO MISUSE BY THE CUSTOMER, NO ACTIONS ARE BEING TAKEN AT THIS TIME.

Description of Event or Problem

FLUID WARMER DRAPE WAS PLACED IN BIRD BATH WARMER DEVICE AND SULFAMYLON WITH EPINEPHRINE WAS POURED INTO WARMER. LAP SPONGES WERE PLACED IN THE WARMING BATH DURING THE PROCEDURE. AT THE END OF THE CASE, THE WARMER DRAPE WAS NOTED TO HAVE A HOLE. STAFF DID NOT IDENTIFY ANY CONCERNS WHILE INSTALLING THE DRAPE ON THE FLUID WARMING UNIT. THE SURGEON WAS NOTIFIED AND NO ADDITIONAL ACTIONS WERE TAKEN FOR THE PATIENT (SURGERY WAS A WOUND DEBRIDEMENT). THE DRAPE WAS SAVED TO RETURN TO THE MANUFACTURER AND THE WARMING EQUIPMENT WAS QUARANTINED AND TAKEN TO BIOMED TO TEST TO ENSURE WORKING CORRECTLY. THE UNIT WAS TESTED AND PASSED BIOMED TESTING. STAFF WERE NOT AWARE OF ANY AIRPOCKETS DURING THE PROCEDURE, NO INSTRUMENTS WERE PLACED IN THE WARMER DURING THE CASE THAT WOULD HAVE POSSIBLY PERFORATED THE DRAPE. THE WARMER HAD FLUID IN THE BASIN BEFORE THE UNIT WAS TURNED ON TO HEAT THE SOLUTION AND THE SETTING DURING THE PROCEDURE WAS 105 DEGREES.