ECOLAB
Received Jun 17, 2016 · Event occurred May 27, 2016
Report 1047429-2016-00015 · MDR key 5733360
Device
Product problems
- Fluid/Blood Leak
- Hole In Material
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
AVID MEDICAL, AN OWENS & MINOR COMPANY, IS THE MANUFACTURER OF A CUSTOM PROCEDURE TRAY THAT CONTAINS DRAPE SLUSH WARMER DISC 44X66, PART # ORS-320N MANUFACTURED BY ECOLAB. AVID MEDICAL RECEIVED A COMPLAINT FROM (B)(6) ON 05/27/2016 THAT ORIGINATED WITH (B)(6), FROM (B)(6). THEIR CUSTOMER STATED THAT THERE WAS A HOLE WITHIN THE SLUSH DRAPE. SOLUTION WAS POOLING IN THE MACHINE UNDER THE DRAPE DURING AN AORTIC ANEURYSM REPAIR/AORTIC VALVE REPLACEMENT. MACHINE AND DRAPE WERE REMOVED AND REPLACED WITHOUT FURTHER INCIDENT. THE COMPLAINED DRAPE WAS AVAILABLE FOR EVALUATION. AVID MEDICAL ISSUED FORMAL (B)(4) TO THE MANUFACTURER ECOLAB FOR A HOLE IN THE SLUSH DRAPE PART # ORS-320N. THE DRAPE LOT # ARE AS FOLLOWS: D151751RC, D151521RC, D151811RC, D151471RC, D151461RC, D151591RC, D151681RC, D152461. NO PATIENT INJURY WAS REPORTED. MEDWATCH NO. 1423395-2016-00038 WAS SUBMITTED BY MEDLINE INDUSTRIES INC.