WARMER DRAPE
Received Feb 4, 2016 · Event occurred Jul 27, 2014
Report 8043817-2016-00007 · MDR key 5411339
Device
Generic name
Fluid Warming And Slush Drapes
Manufacturer
Microtek Dominicana, S.a.Model number
ORS-320Lot number
UNKNOWN
Product problems
- Hole In Material
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
SINCE THERE WAS NO LOT NUMBER OR DEFECTIVE PRODUCT PROVIDED, THE NON-CONFORMITY COULD NOT BE VERIFIED. 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. SINCE NO DEVICE WAS RETURNED FOR ANALYSIS, THE ROOT CAUSE FOR THE EVENT HAS NOT BEEN DETERMINED.
Description of Event or Problem
AN END USER FOUND HOLES IN THE FLUID WARMER DRAPES, CREATING INFECTION CONTROL CONCERNS IN SURGICAL SETTING. THERE WERE NO PATIENT INJURY AND TREATMENT REPORTED OF THE INCIDENT.
Additional Manufacturer Narrative
SINCE THERE WAS NO LOT NUMBER OR DEFECTIVE PRODUCT PROVIDED, THE NON-CONFORMITY COULD NOT BE VERIFIED. 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. SINCE NO DEVICE WAS RETURNED FOR ANALYSIS, THE ROOT CAUSE FOR THE EVENT HAS NOT BEEN DETERMINED.
Description of Event or Problem
END USER FOUND HOLES IN THE FLUID WARMER DRAPES, CREATING INFECTION CONTROL CONCERNS IN SURGICAL SETTING. THERE WAS NO PATIENT INJURY OR TREATMENT REPORTED FOR THE INCIDENT.
Additional Manufacturer Narrative
SINCE THERE WAS NO LOT NUMBER OR DEFECTIVE PRODUCT PROVIDED, THE NON-CONFORMITY COULD NOT BE VERIFIED. 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. SINCE NO DEVICE WAS RETURNED FOR ANALYSIS, THE ROOT CAUSE FOR THE EVENT HAS NOT BEEN DETERMINED.
Description of Event or Problem
END USER FOUND HOLES IN THE FLUID WARMER DRAPES, CREATING INFECTION CONTROL CONCERNS IN SURGICAL SETTING. THERE WAS NO PATIENT INJURY OR TREATMENT REPORTED FOR THE INCIDENT.