inforMED
MalfunctionLHC

WARMER DRAPE

Received May 4, 2016

Report 8043817-2016-00031 · MDR key 5632415

Device

Generic name

Fluid Warming And Slush Drapes

Model number

ORS-188231

Lot number

D152933 D152873

Product problems

  • Hole In Material
  • Leak/Splash

Patient

Not reported

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

Narrative

Additional Manufacturer Narrative

BASED ON THE DHR REVIEW, THE DRAPE WAS MANUFACTURED TO SPECIFICATIONS AND DOES NOT APPEAR TO BE THE RESULT OF A PERSONNEL, PROCESS OR MATERIALS ISSUE. NO DEFECT WERE REPORTED IN PROCESS,PACKAGING OR FINAL INSPECTION. 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; AND/OR IF THE WARMER IS OPERATED CONTRARY TO THE OPERATIONS MANUAL, PRODUCT LABELING, PRODUCT INSERT AND IN-SERVICE PRESENTATIONS. SINCE NO SAMPLE WAS RETURNED FOR REVIEW, THE NON CONFORMITY COULD NOT BE CONFIRMED AND NO ADDITIONAL ACTIONS WILL BE TAKEN AT THIS TIME.

Description of Event or Problem

AN END USER REPORTS POSSIBILITY OF HOLE IN DRAPE. THERE WAS WATER IN THE WARMER AFTER CASE. THE STAFF TESTED DRAPE AFTER CASE BY PLACING WATER IN DRAPE OVER A SINK AND THEY SAW LEAKING. THERE WERE NO PATIENT INJURY AND TREATMENT REPORTED OF THE INCIDENT.

Additional Manufacturer Narrative

BASED ON THE DHR REVIEW, THE DRAPE WAS MANUFACTURED TO SPECIFICATIONS AND DOES NOT APPEAR TO BE THE RESULT OF A PERSONNEL, PROCESS OR MATERIALS ISSUE. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING, OR FINAL INSPECTION. 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; AND/OR IF THE WARMER IS OPERATED CONTRARY TO THE OPERATIONS MANUAL, PRODUCT LABELING, PRODUCT INSERT AND IN-SERVICE PRESENTATIONS. SINCE NO SAMPLE WAS RETURNED FOR REVIEW, THE NON CONFORMITY COULD NOT BE CONFIRMED AND NO ADDITIONAL ACTIONS WILL BE TAKEN AT THIS TIME. FOLLOW UP #1: THREE SAMPLES WERE RETURNED ON 4/22/2016. THE DRAPE THAT WAS REPORTED TO HAVE THE NONCONFORMITY WAS OBSERVED TO HAVE THREE SMALL HOLES RIGHT NEXT TO EACH OTHER BY WHICH WATER COULD LEAK THROUGH. A BURN MARK WAS OBSERVED ABOUT 9 INCHES FROM THE HOLES BUT WATER WAS NOT ABLE TO LEAK THROUGH THE MARK. THE TWO UNUSED DRAPES WERE EXAMINED AND NO LEAKS, HOLES, OR BURN MARKS WERE OBSERVED. THE DHR WAS REVIEWED FOR LOT D152873 AND IT WAS SEEN THAT THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 10/15/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING, OR FINAL INSPECTION. THE DHR WAS REVIEWED FOR LOT D152933 AND IT WAS SEEN THAT THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 10/20/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. AFTER REVIEW OF THE DEVICE HISTORY RECORD AND THE SAMPLE, IT HAS BEEN CONCLUDED THAT THE HOLES APPEAR TO BE THE RESULT OF A SHARP OBJECT PLACED IN THE BASIN. THERE IS ALSO A BURN MARK. BECAUSE OF THIS, IT DOES NOT APPEAR TO BE THE RESULT OF A PERSONNEL, PROCESS, OR MATERIAL ISSUE.

Description of Event or Problem

AN END USER REPORTS POSSIBILITY OF HOLE IN DRAPE. THERE WAS WATER IN THE WARMER AFTER CASE. THE STAFF TESTED DRAPE AFTER CASE BY PLACING WATER IN DRAPE OVER A SINK AND THEY SAW LEAKING. THERE WERE NO PATIENT INJURY AND TREATMENT REPORTED OF THE INCIDENT.