ORS FLUID WARMER
Received Jan 4, 2016 · Event occurred Nov 2, 2015
Report 1043582-2016-00001 · MDR key 5342361
Device
Product problems
- Fluid/Blood Leak
- Device Operates Differently Than Expected
- Temperature Problem
Patient
39 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE CUSTOMER WAS CONTACTED FOR ADDITIONAL INFORMATION AND WANTED TO WAIT FOR THEIR BIOMED DEPARTMENT TO CHECK OUT THE UNIT BEFORE SENDING IT FOR INSPECTION AND REPLACEMENT. NO PRODUCT HAS BEEN RETURNED. SINCE NO DEVICE WAS RETURNED FOR ANALYSIS, THE ROOT CAUSE FOR THE EVENT HAS NOT BEEN DETERMINED.
Description of Event or Problem
DURING OPERATING ROOM CLEAN UP, AFTER COMPLETION OF THE SURGERY, THE WARMING DRAPE WAS REMOVED FROM THE SOLUTION WARMER. THE SURGICAL TECHNICIAN NOTED THERE WAS LIQUID UNDER THE DRAPE AND THE TEMPERATURE ON THE WARMER HAD RISEN TO 107 DEGREES WITHOUT ANYONE CHANGING THE PRESET TEMPERATURE. THE DRAPE WAS INSPECTED. NO VISIBLE HOLE WAS FOUND. THE SURGEON WAS NOTIFIED AND THE WARMER WAS TAKEN OUT OF SERVICE.