SOLUTION WARMER
Received Mar 11, 2016 · Event occurred Jan 25, 2016
Report 1043582-2016-00003 · MDR key 5496085
Device
Product problems
- Temperature Problem
- Noise, Audible
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
FACILITY'S CLINICAL ENGINEERING FROM (B)(6) MEDICAL CENTER TESTED THE UNIT TWICE AND FOUND IT TO WORK TO MANUFACTURER'S SPECIFICATIONS, IT DOES NOT APPEAR TO BE PERSONNEL, PROCESS OR MATERIALS ISSUE. THE ISSUE COULD HAVE BEEN THE RESULT OF MISUSE OR MISAPPLICATION OF THE DRAPE. 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; AND/OR IF THE WARMER IS OPERATED CONTRARY TO THE OPERATIONS MANUAL, PRODUCT LABELING, PRODUCT INSERT AND IN-SERVICE PRESENTATIONS.
Description of Event or Problem
NURSE FROM (B)(6) MEDICAL CENTER CALLED MICROTEK-ECOLAB AND DESCRIBED AS FOLLOWS - SURGEON PERFORMED AN ABDOMINAL AORTIC ANEURYSM REPAIR WITH A START TIME OF APPROX. 9:36; THE TEMPERATURE WARMER WAS SET TO 120, AND HOSPITAL STAFF POURED FLUIDS INTO SLUSH BASIN AND WARMING BASIN. NO ADDITIONAL EQUIPMENT WAS PLACED INSIDE THE SLUSH BASIN AND AUTO STIR WAS FUNCTIONING PROPERLY. THERE WAS NO ISSUE REPORTED THAT DAY. THE FOLLOWING DAY, THE NURSE REPORTED THAT THE BASIN DID NOT COOL AND AN AUDIBLE CLICK IS HEARD EVERY 5-10 SEC. THE NURSE QUARANTINED THE MACHINE AND CALLED A MICROTEK-ECOLAB SALE REPRESENTATIVE FOR FURTHER DIRECTION. ACCORDING TO THE NURSE, PATIENT SAFETY HAS NOT BEEN COMPROMISED AND NO ADDITIONAL MODES OF COILING WERE NEEDED.