BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SORIN WATER HEATER/COOLER

    MDR report key: 5962756 · Received September 16, 2016

    Report

    Report Number
    MW5064834
    Event Type
    Malfunction
    Date Received
    September 16, 2016
    Report Date
    September 16, 2016
    Manufacturer
    SORIN
    Product Code
    DWC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ROUTINE LAB TESTING OF SORIN WATER HEATER/COOLER MACHINE REVEALED THE PRESENCE OF NTB. ON (B)(6) 2016; 40 CFU/ML OF MYCOBACTERIUM CHIMAERA ISOLATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609986 SORIN WATER HEATER/COOLER SORIN WATER HEATER/COOLER DWC SORIN

    Patients

    Seq Age Sex Outcome Treatment
    1