MalfunctionLHC
SOLUTION WARMER
Received Nov 17, 2015 · Event occurred Nov 2, 2015
Report 5229191 · MDR key 5229191
Device
Product problems
- Self-Activation or Keying
- Device Operates Differently Than Expected
Patient
39 YR
- No Known Impact Or Consequence To Patient
Narrative
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 THAT 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.