inforMED

AMSCO WARMING CABINET

Received Sep 15, 2015 · Event occurred Aug 21, 2015

Report 1043572-2015-00086 · MDR key 5078282

Device

Generic name

Warming Cabinet

Product problems

  • Insufficient Device Problem Information

Patient

Not reported

  • Burn(s)

Narrative

Additional Manufacturer Narrative

THERE ARE FOUR WARMING CABINETS IN USE AT THE USER FACILITY. THE USER FACILITY REPORTED THAT IT IS UNKNOWN WHICH WARMING CABINET PROVIDED THE SOLUTION SUBJECT OF THE REPORTED EVENT. A STERIS FIELD SERVICE TECHNICIAN ARRIVED ONSITE, INSPECTED ALL FOUR WARMING CABINETS, AND WAS UNABLE TO IDENTIFY ANY ISSUE WITH THE UNITS. THE WARMING CABINETS ALL WERE WITHIN SPECIFICATION FOR TEMPERATURE (100º F - 115º F). NO ADDITIONAL ISSUES HAVE BEEN REPORTED. THE WARMING CABINETS ARE UNDER STERIS CONTRACT AGREEMENTS FOR MAINTENANCE. STERIS WARMING CABINETS ARE CAPABLE OF WARMING FLUIDS, HOWEVER THE USER SHOULD ALWAYS FOLLOW THE SPECIFIC INSTRUCTION OF THE MANUFACTURER OF THE SOLUTION PRIOR TO WARMING ANY FLUID. THE TECHNICIAN DISCUSSED THE IMPORTANCE OF FOLLOWING THE MANUFACTURER'S INSTRUCTIONS FOR USE REGARDING THE SALINE SOLUTION PRIOR TO USE WITH THE WARMING CABINET.

Description of Event or Problem

THE USER FACILITY REPORTED THAT WHILE PREPARING A PATIENT FOR A PROCEDURE, THE PATIENT RECEIVED A BURN FROM WARMED SALINE SOLUTION. THE USER FACILITY DECLINED TO PROVIDE ADDITIONAL INFORMATION REGARDING THE PATIENT. NO REPORT OF A PROCEDURAL DELAY OR CANCELLATION.