WARMER DRAPE
Received May 31, 2017
Report 8043817-2017-00014 · MDR key 6602578
Device
Generic name
Fluid Warming And Slush Drapes
Manufacturer
Microtek Dominicana, S.a.Model number
ORS-100Lot number
UNKNOWN
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
NO LOT NUMBER, SAMPLE, OR PICTURE HAVE BEEN RECEIVED FOR THIS REPORTED NON CONFORMITY. THE INVESTIGATION IS PENDING RECEIPT OF A SAMPLE. NO ACTIONS HAVE BEEN TAKEN AT THIS TIME.
Description of Event or Problem
END USER NOTICED THAT THERE WAS A HOLE IN THE DRAPE AT THE END OF THE PROCEDURE. THERE WAS A LOT OF FLUID THAT HAD LEAKED INTO THE BASIN. NO PATIENT INJURY OR TREATMENT WAS REPORTED FOR THE INCIDENT.
Additional Manufacturer Narrative
A SAMPLE WAS RECEIVED BUT INADVERTENTLY MISPLACED. SINCE A LOT NUMBER WAS NOT PROVIDED, A DEVICE HISTORY RECORD REVIEW WAS NOT COMPLETED. SINCE A LOT NUMBER WAS NOT PROVIDED AND THE SAMPLE COULD NOT BE REVIEWED, THE NON CONFORMITY WAS NOT ABLE TO BE CONFIRMED AS A PERSONNEL, PROCESS, OR MATERIAL ISSUE. BECAUSE A SAMPLE WAS NOT REVIEWED AND THE DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED, THE NON CONFORMITY COULD NOT BE CONFIRMED. NO ADDITIONAL ACTIONS WILL BE TAKEN AT THIS TIME. 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.
Description of Event or Problem
END USER NOTICED THAT THERE WAS A HOLE IN THE DRAPE AT THE END OF THE PROCEDURE. THERE WAS A LOT OF FLUID THAT HAD LEAKED INTO THE BASIN. NO PATIENT INJURY OR TREATMENT WAS REPORTED FOR THE INCIDENT.