MalfunctionLHC
ORS-331 SLUSH WARMER DRAPE WITH PLATE
Received Aug 11, 2017 · Event occurred Jul 24, 2017
Report 8043817-2017-00020 · MDR key 6789045
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
AT THE TIME OF THIS REPORT, NO LOT NUMBER OR SAMPLE HAD BEEN PROVIDED. AS NO DEVICE WAS AVAILABLE FOR EVALUATION, THE ROOT CAUSE OF THIS COMPLAINT CANNOT BE CONFIRMED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.
Description of Event or Problem
END USER REPORTED "AT THE END OF THE OPEN HEART PROCEDURE, THE SLUSH/WARMER DRAPE HAD POOLING IN THE WARM SIDE. THIS INDICATES A HOLE IN THE DRAPE PRIOR TO PROCEDURE." NO PATIENT INJURY OR TREATMENT WAS REPORTED FOR THE INCIDENT.