BEUDAMED
    FDA Adverse Event Summary report: N

    ECOLAB

    MDR report key: 5733360 · Received June 17, 2016

    Report

    Report Number
    1047429-2016-00015
    Date Received
    June 17, 2016
    Date of Event
    May 27, 2016
    Report Date
    June 17, 2016
    Manufacturer
    ECOLAB
    Product Code
    LHC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388716 ECOLAB SLUSH WARMER DRAPE LHC ECOLAB ORS-320N D151751RC, D151521RC, D151811R

    Patients

    Seq Age Sex Outcome Treatment
    1