WARMER DRAPE

Additional Manufacturer Narrative

ONE SAMPLE FROM THE LOT 1044537 WAS RECEIVED ON 12/30/2015 AND REVIEWED ON 1/7/2016. THE SAMPLE DRAPE WAS SOAKED IN BLEACH FOR ABOUT 1.25 HOURS, RINSED AND DRIED. CHECKED SAMPLE, BURN MARK WAS CIRCLED AND TOOK PHOTOS. CUSTOMER NOTED IN THEIR COMPLAINT FORM THERE WAS A BURN MARK. CHECKED SAMPLE AND BURN MARK WAS CIRCLED. IT WAS ABOUT 17 INCHES TO THE RIGHT OF THE SLUSH PLATE AND 8 INCHES DOWN. BURN MARK WAS ON THE DRAPE WHERE IT WOULD HAVE BEEN PLACED ON THE WARMER. BURN CAN OCCUR WHEN THE WARMER IS NOT DRAPED PROPERLY OR 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

DURING THE MIDDLE OF THE CASE, SCRUB TECH NOTICED THE SALINE LEVEL ON THE WARM COMPARTMENT WAS GETTING LOW. ANOTHER LITER OF SALINE WAS ADDED BUT NOTICED THAT THE DRAPE WAS NOT ADHERING TO THE SIDES OF THE WARM COMPARTMENT. AFTER CAREFUL INSPECTION, SCRUB FOUND OUT THERE WAS A POOL OF SALINE UNDER THE DRAPE. NOTED A HOLE (BURN MARK) ON THE DRAPE. BIOMED CHECKED THE MACHINE AND WAS FOUND TO BE WITHIN SPECS.

Additional Manufacturer Narrative

ONE SAMPLE FROM THE LOT 1044537 WAS RECEIVED ON 12/30/2015 AND REVIEWED ON 1/7/2016 . THE SAMPLE DRAPE WAS SOAKED IN BLEACH FOR ABOUT 1.25 HOURS, RINSED AND DRIED. CHECKED SAMPLE, BURN MARK WAS CIRCLED AND TOOK PHOTOS. CUSTOMER NOTED IN THEIR COMPLAINT FORM THERE WAS A BURN MARK. CHECKED SAMPLE AND BURN MARK WAS CIRCLED. IT WAS ABOUT 17 INCHES TO THE RIGHT OF THE SLUSH PLATE AND 8 INCHES DOWN. BURN MARK WAS ON THE DRAPE WHERE IT WOULD HAVE BEEN PLACED ON THE WARMER. BURN CAN OCCUR WHEN THE WARMER IS NOT DRAPED PROPERLY OR 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. FOLLOW UP #1: LOT 1044537 WAS REPORTED FOR THIS COMPLAINT. THIS IS THE STERILE LOT FROM MEDICAL ACTION WHICH CORRESPONDS TO THE MICROTEK NON STERILE LOTS D152711, D152691, D152641. THE DHR WAS REVIEWED FOR LOT D152871. THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 09/28/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. THE DHR WAS REVIEWED FOR LOT D152691. THIS LOT HAD (B)(4) PCS AND WAS MANUFACTURED ON 9/29/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING, OR FINAL INSPECTION. THE DHR WAS REVIEWED FOR LOT D152641. THIS LOT HAD (B)(4) PCS AND WAS MANUFACTURED ON 09/21/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING, OR FINAL INSPECTION. AFTER REVIEWING THE SAMPLE, IT HAS BEEN CONCLUDED THAT THE NON CONFORMITY (HOLE) IS A BURN. BASED ON THE DHR REVIEW, IT DOES NOT APPEAR TO BE THE RESULT OF A PERSONNEL, PROCESS OR MATERIAL ISSUE.

Description of Event or Problem

DURING THE MIDDLE OF THE CASE, SCRUB TECH NOTICED THE SALINE LEVEL ON THE WARM COMPARTMENT WAS GETTING LOW. ANOTHER LITER OF SALINE WAS ADDED BUT NOTICED THAT THE DRAPE WAS NOT ADHERING TO THE SIDES OF THE WARM COMPARTMENT. AFTER CAREFUL INSPECTION, SCRUB FOUND OUT THERE WAS A POOL OF SALINE UNDER THE DRAPE. NOTED A HOLE (BURN MARK) ON THE DRAPE. BIOMED CHECKED THE MACHINE AND WAS FOUND TO BE WITHIN SPEC.