inforMED
MalfunctionLHC

ORS-321 SLUSH WARMER DRAPE

Received Sep 7, 2016

Report 8043817-2016-00048 · MDR key 5934137

Device

Generic name

Fluid Warming And Slush Drapes

Model number

ORS-321

Lot number

D160461

Product problems

  • Thermal Decomposition of Device
  • Contamination
  • Hole In Material

Patient

Not reported

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Additional Manufacturer Narrative

THE COMPLAINT INVOLVED TWO SEPARATE DEVICES. THIS IS THE REPORT FOR THE SECOND DEVICE. THE DEVICE HAS BEEN RETURNED FOR EVALUATION HOWEVER, THE RESULTS OF THE INVESTIGATION ARE NOT YET COMPLETE. WHEN THE RESULTS ARE AVAILABLE A FOLLOW-UP REPORT WILL BE FILED. FOLLOW UP #1 THE DEVICE HISTORY RECORD WAS REVIEWED. THIS LOT HAD (B)(4) PIECES AND WAS MANUFACTURED ON 02/15/2016. NO DEFECTS WERE REPORTED DURING IN PROCESS OR PACKAGING INSPECTION. TWO SAMPLES WERE RECEIVED. THE FIRST DRAPE HAD A BURN HOLE ABOUT (B)(4) INCHES FROM THE SLUSH PLATE ON THE WARMER SIDE. IT ALSO HAD A SMALL BURN MARK ABOUT (B)(4) INCHES FROM THE SLUSH PLATE ON THE WARMER SIDE. THE SECOND DRAPE HAD A BURN MARK WITH A SMALL BURN HOLE ABOUT 16 1/2 INCHES FROM THE SLUSH PLATE ON THE WARMER SIDE. BASED ON THE SAMPLE AND THE DEVICE HISTORY RECORD REVIEW, THIS DOES NOT APPEAR TO BE RELATED TO 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 MISUSE BY THE CUSTOMER, NO ADDITIONAL ACTIONS ARE BEING TAKEN AT THIS TIME.

Description of Event or Problem

IT WAS REPORTED THAT A CUSTOMER HAD TWO INCIDENTS THE FIRST WEEK OF (B)(6) WHERE HOLES WERE BURNED INTO THE DRAPE. THE CUSTOMER IS USING A STAINLESS GRADUATE WITH LAP SPONGES IN THE BASIN. THE HOLES CAUSED CONTAMINATION OF THE STERILE FIELD IN THE BASIN. THE HOLES WERE IN THE SAME EXACT SPOT IN BOTH DRAPES.

Additional Manufacturer Narrative

THE COMPLAINT INVOLVED TWO SEPARATE DEVICES. THIS IS THE REPORT FOR THE SECOND DEVICE. THE DEVICE HAS BEEN RETURNED FOR EVALUATION HOWEVER, THE RESULTS OF THE INVESTIGATION ARE NOT YET COMPLETE. WHEN THE RESULTS ARE AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT A CUSTOMER HAD TWO INCIDENTS THE FIRST WEEK OF (B)(6) WHERE HOLES WERE BURNED INTO THE DRAPE. THE CUSTOMER IS USING A STAINLESS GRADUATE WITH LAP SPONGES IN THE BASIN. THE HOLES CAUSED CONTAMINATION OF THE STERILE FIELD IN THE BASIN. THE HOLES WERE IN THE SAME EXACT SPOT IN BOTH DRAPES.