WARMER DRAPE
Received May 22, 2017 · Event occurred Apr 27, 2017
Report 8043817-2017-00012 · MDR key 6582773
Device
Generic name
Fluid Warming And Slush Drapes
Manufacturer
Microtek Dominicana, S.a.Model number
ORS-300Lot number
D163491
Product problems
- 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 FOR THIS COMPLAINT WAS EVALUATED AND OBSERVED TO HAVE A BURN MARK/HOLE ABOUT 4 1/2 INCHES FROM CENTER OF DRAPE. IT APPEARS TO HAVE COME FROM SOMETHING PLACED IN THE BASIN. THE DHR WAS REVIEWED AND IT WAS NOTICED THAT THIS LOT HAD 4080PCS THAT WERE MANUFACTURED FROM 12/15/2016 TO 12/16/2016. NO DEFECTS WERE REPORTED DURING QUALITY INSPECTION. THIS LOT WAS MANUFACTURED IN COMBINED SHIFTS. BASED ON THE SAMPLE AND DHR REVIEW, THIS DOES NOT APPEAR TO BE THE RESULT OF A PERSONNEL ISSUE, PROCESS, OR MATERIALS 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 A "HOLE" IN DRAPE FOUND DURING A PATIENT PROCEDURE ON (B)(6) 2017. DRAPE AND WARMER WERE SENT TO THEIR BIOMED DEPARTMENT AS PER THEIR HOSPITAL PROCEDURE FOR TESTING PRIOR TO RELEASING FOR PICKUP AND COMPLAINT FILING. NO PATIENT INJURY OR TREATMENT WAS REPORTED FOR THE INCIDENT.