WARMER DRAPE
Received Apr 14, 2017 · Event occurred Mar 15, 2017
Report 8043817-2017-00007 · MDR key 6493729
Device
Generic name
Fluid Warming And Slush Drapes
Manufacturer
Microtek Dominicana, S.a.Model number
ORS-320Lot number
D163331
Product problems
- Fluid/Blood Leak
- 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 SAMPLE RECEIVED WAS EVALUATED AND OBSERVED TO HAVE A BURN MARK WITH A SMALL BURN HOLE ABOUT 12 1/2 INCHES FROM THE SLUSH DISC. THE DHR WAS REVIEWED AND IT WAS NOTICED THAT THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 11/28/2016. 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
END USER REPORTED THAT AT THE END OF CASE WHEN DRAPE WAS TAKEN OUT OF THE MACHINE, A HOLE WAS NOTICED THAT LEAKED THE WATER AND ICE OUT. THIS BREAKS THE STERILITY OF THE DRAPE. THIS IS THE 3RD INCIDENT THAT THIS HAS HAPPENED. HOWEVER THE ONLY SAMPLE AVAILABLE IS FROM THE MOST RECENT CASE ON (B)(6) 2017. NO PATIENT INJURY OR TREATMENT WAS REPORTED FOR THE INCIDENT.