ORS-320 SLUSH WARMER DISC DRAPE
Received Nov 22, 2017
Report 8043817-2017-00031 · MDR key 7052791
Device
Generic name
Fluid Warming And Slush Drapes
Manufacturer
Microtek Dominicana, S.a.Model number
ORS-320Lot number
D171841
Product problems
- Hole In Material
- 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 SAMPLES WERE RETURNED FOR THIS INVESTIGATION. THE DHR WAS REVIEWED FOR THIS LOT AND IT WAS NOTICED THAT (B)(4) CASES WERE MANUFACTURED FROM 07/04/2017 TO 07/09/2017. NO DEFECTS WERE REPORTED DURING QUALITY INSPECTION. BASED ON THE DHR 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 NO SAMPLE WAS PROVIDED AND THE NON CONFORMANCE COULD NOT BE CONFIRMED, NO ADDITIONAL ACTIONS WILL BE TAKEN AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.
Description of Event or Problem
END USER REPORTED " WE ARE UNSURE IF THE LEAK WAS DUE TO THE DRAPE, OR THE MACHINE MALFUNCTIONING. WE BAGGED THE DRAPE AND SENT IT FOR INSPECTION, AND REPORTED THE MACHINE INVOLVED. THIS HAS HAPPENED MULITPLE TIMES ALREADY. THE CONSEQUENCES COULD BE VERY SERIOUS FOR THE PATIENT IN TERMS OF INFECTION. WE COULD BE IRRIGATING THE PATIENT'S HEART WITH UNSTERILE FLUID." NO PATIENT INJURY OR TREATMENT WAS REPORTED FOR THE INCIDENT.