BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1664427 · Received April 12, 2010

    Report

    Report Number
    1664427
    Event Type
    Malfunction
    Date Received
    April 12, 2010
    Date of Event
    April 7, 2010
    Report Date
    April 12, 2010
    Manufacturer
    CINCINNATI SUB-ZERO PRODUCTS, INC
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AN ECMO BLOOD WARMER, MODEL 333W WAS FOUND TO BE LEAKING.THE BIOMEDICAL DEPARTMENT INSPECTED THE DEVICE AND AFTER SPEAKING WITH THE MANUFACTURER LEARNED THAT AN O-RING WAS MISSING. IT WAS NEVER INSERTED DURING THE MANUFACTURING PROCESS. THE O-RING SHOULD HAVE BEEN PLACED ON THE OUTLET OF THE RESEVOIR. THE MANUFACTURER WILL SEND AN O-RING TO BE INSERTED BY OUR BIOMEDICAL DEPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * HEATER, ECMO DWJ CINCINNATI SUB-ZERO PRODUCTS, INC 333W *

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR