WARMER DRAPE
Received Feb 18, 2016
Report 8043817-2016-00017 · MDR key 5445936
Device
Generic name
Fluid Warming And Slush Drapes
Manufacturer
Microtek Dominicana, S.a.Model number
ORS-100NLot number
D152501 D143091
Product problems
- Leak/Splash
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
NO PRODUCT HAS BEEN RETURNED. SINCE NO DEVICE WAS RETURNED FOR ANALYSIS, THE ROOT CAUSE FOR THE EVENT HAS NOT BEEN DETERMINED.
Description of Event or Problem
ECOLAB-MICROTEK SALES REPRESENTATIVE REPORTED THAT THE DRAPE LEAKED INTO THE WARMING PAN. ECOLAB-MICROTEK REPRESENTATIVE STATED THEY DISCOVERED THE LEAK AFTER THE CASE. THE DRAPE WAS USED DURING THE PROCEDURE. THERE WERE NO PATIENT INJURY AND TREATMENT REPORTED OF THE INCIDENT.
Additional Manufacturer Narrative
NO PRODUCT HAS BEEN RETURNED. SINCE NO DEVICE WAS RETURNED FOR ANALYSIS, THE ROOT CAUSE FOR THE EVENT HAS NOT BEEN DETERMINED. FOLLOW UP #1: THE DHR WAS REVIEWED FOR LOT D152503 AND IT WAS SEEN THAT THIS LOT HAD 4800PCS AND IT WAS MANUFACTURED ON 09/07/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING, OR FINAL INSPECTION. THE DHR WAS REVIEWED FOR LOT D143091 AND IT WAS SEEN THAT THIS LOT HAD 4800 PCS AND IT WAS MANUFACTURED ON 11/05/2014. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. BASED ON THE DHR REVIEW THE NON CONFORMITY DOES NOT APPEAR TO BE THE RESULT OF A PERSONNEL, PROCESS OR MATERIAL ISSUE. DUE TO RECEIVING NO SAMPLE THE NON CONFORMITY COULD NOT BE PHYSICALLY CONFIRMED. 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.
Description of Event or Problem
SALES REP REPORTS THAT THE DRAPE LEAKED INTO THE WARMING PAN. REP STATED THEY DISCOVERED THE LEAK AFTER THE CASE. THE DRAPE WAS USED DURING THE PROCEDURE. NO PATIENT INJURY OR TREATMENT WERE REPORTED FOR THE INCIDENT.