inforMED
MalfunctionLHC

WARMER DRAPE

Received Mar 27, 2017

Report 8043817-2017-00006 · MDR key 6436297

Device

Generic name

Fluid Warming And Slush Drapes

Model number

ORS-320

Lot number

D162351

Product problems

  • Fluid/Blood Leak
  • Hole In Material

Patient

Not reported

  • No Information
  • No Information

Narrative

Additional Manufacturer Narrative

THE USED DRAPE AS WELL AS UNOPENED DRAPES FROM THE SAME LOT WERE RECEIVED FOR EVALUATION. THE USED DRAPED WAS OBSERVED TO HAVE TWO SMALL BURN MARKS. ONE OF THE BURN MARKS HAD A SMALL BURN HOLE ABOUT 21 INCHES FROM THE SLUSH PLATE ON THE WARMER SIDE. THE UNOPENED DRAPES DIDN NOT HAVE ANY HOLES. THE DHR WAS REVIEWED AND IT WAS NOTICED THAT THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 08/23/16. NO DEFECTS WERE REPORTED DURING QUALITY INSPECTIONS. THIS LOT WAS MANUFACTURED IN COMBINED SHIFTS. BASED ON THE SAMPLE AND DEVICE HISTORY RECORD REVIEW, THIS DOES NOT APPEAR TO BE THE RESULT OF 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 RELATED TO MISUSE BY THE CUSTOMER, NO ACTIONS ARE BEING TAKEN AT THIS TIME.

Description of Event or Problem

AN END USER REPORTED HOLES IN ORS-320 DRAPE AFTER USE. AT THE END OF THE CASE, SUCTION WAS USED TO REMOVE THE FLUID AND TWO HOLES WERE OBSERVED IN THE DRAPE AS WELL AS AN INCH OF FLUID IN THE BASIN, UNDER THE DRAPE. THE MINIMUM FLUID LEVELS WERE MAINTAINED AT ALL TIMES AND THE WARMER WAS SET TO 120. TWO ASEPTOS, ONE METAL GRADUATE, AND SOME LAPS HAD BEEN IN THE BASIN.