WARMER DRAPE
Received Feb 4, 2016 · Event occurred Aug 5, 2013
Report 8043817-2016-00006 · MDR key 5410197
Device
Generic name
Fluid Warming And Slush Drapes
Manufacturer
Microtek Dominicana, S.a.Model number
UNKNOWNLot number
UNKNOWN
Product problems
- Fluid/Blood Leak
- Melted
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THERE ARE NO SAMPLES TO REVIEW SINCE THE MEDWATCH WAS SUBMITTED IN 2013. MELTS 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. SINCE NO DEVICE WAS RETURNED FOR ANALYSIS THE ROOT CAUSE FOR THE EVENT HAS NOT BEEN DETERMINED.
Description of Event or Problem
THE MICROFIBER WARMER DRAPE WAS FOUND TO HAVE A 1CM MELTED PORTION WHEN IT WAS REMOVED FROM THE FLUID WARMER. FLUID WAS ALSO NOTED TO HAVE LEAKED INTO THE BOTTOM OF THE FLUID WARMER VIA A HOLE IN THE MELTED PORTION OF THE DRAPE.
Additional Manufacturer Narrative
THERE ARE NO SAMPLES TO REVIEW SINCE THE MEDWATCH WAS SUBMITTED IN 2013. MELTS 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. SINCE NO DEVICE WAS RETURNED FOR ANALYSIS THE ROOT CAUSE FOR THE EVENT HAS NOT BEEN DETERMINED.
Description of Event or Problem
THE MICROFIBER WARMER DRAPE WAS FOUND TO HAVE A 1CM MELTED PORTION WHEN IT WAS REMOVED FROM THE FLUID WARMER. FLUID WAS ALSO NOTED TO HAVE LEAKED INTO THE BOTTOM OF THE FLUID WARMER VIA A HOLE IN THE MELTED PORTION OF THE DRAPE.