BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE BETTER BLADDER

    MDR report key: 5462942 · Received February 23, 2016

    Report

    Report Number
    MW5060526
    Event Type
    Malfunction
    Date Received
    February 23, 2016
    Date of Event
    February 19, 2016
    Report Date
    February 23, 2016
    Manufacturer
    CIRCULATORY TECHNOLOGY INC.
    Product Code
    DTN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ONE PART, "THE BETTER BLADDER" (MM ITEM (B)(4)), THAT MAKES UP THE ECMO CIRCUIT WAS FOUND TO BE DEFECTIVE DURING CIRCUIT PRIMING AND HAD TO BE REMOVED AND REPLACED WITH A NEW BETTER BLADDER. THE PART HAD BEEN PRIMED WITH DONOR BLOOD BUT THE CIRCUIT WAS NOT CONNECTED TO A PT UNTIL AFTER THE PART WAS REPLACED. THERE WAS NO HARM TO THE PT AND THERE WAS NO DELAY IN TREATMENT. ECMO INITIATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111524 THE BETTER BLADDER ECMO, CIRCUIT BLADDER DTN CIRCULATORY TECHNOLOGY INC. 014882

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR