ORS-331 SLUSH WARMER DRAPE WITH PLATE
Received Sep 20, 2017
Report 8043817-2017-00027 · MDR key 6878911
Device
Generic name
Fluid Warming And Slush Drapes
Manufacturer
Microtek Dominicana, S.a.Model number
ORS-331Lot number
UNKNOWN
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
A SAMPLE WAS RECEIVED FOR EVALUATION. DURING VISUAL INSPECTION, A HOLE WAS NOT FOUND. THE DRAPE WAS PLACED OVER A WARMER AND ABOUT TWO LITERS OF WATER WERE ADDED TO THE BASIN TO CHECK FOR LEAKS. NO LEAKS WERE FOUND. NO LOT NUMBER WAS NOT PROVIDED FOR THIS COMPLAINT; THEREFORE, A DEVICE HISTORY RECORD COULD NOT BE PERFORMED. SINCE THE SAMPLE REVIEW DID NOT CONFIRM THE NON CONFORMITY, THIS DOES NOT APPEAR TO BE THE RESULT OF A PERSONNEL, PROCESS OR MATERIAL ISSUE AND THE INVESTIGATION IS INCONCLUSIVE. NO FURTHER ACTIONS WILL BE TAKEN AT THIS TIME.
Description of Event or Problem
CARDINAL IS REPORTING THAT (B)(6) MEDICAL CENTER HAS NOTIFIED THEM OF A HOLE IN ORS-331 THAT COMES IN A CARDINAL OPEN HEART PACK. THEY INDICATED THAT THE HOLE WAS ON THE WARMER SIDE OF THE DRAPE. NO PATIENT INJURY OR TREATMENT WAS REPORTED FOR THE INCIDENT.