BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECMO 1500

    MDR report key: 1871446 · Received September 27, 2010

    Report

    Report Number
    1871446
    Event Type
    Malfunction
    Date Received
    September 27, 2010
    Date of Event
    September 16, 2010
    Report Date
    September 21, 2010
    Manufacturer
    MEDTRONIC INC.
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    DURING THE ROUTINE PRIMING OF A BACK-UP ECMO CIRCUIT THE MEMBRANE LEAKED. THE MEMBRANE WAS LEAKING. THE DEVICE WAS IN CONTACT WITH THE PATIENT AND THE PATIENT WAS WEANED OFF ECMO. WE HAVE EXPERIENCED A TOTAL OF SIX CRACKED QUADROX MEMBRANES IN THREE PTS IN THE LAST TWO YEARS. ONE LAST YEAR AND TWO THIS YEAR. THE SIX MEMBRANES CRACKED AT VARIOUS HOURS OF USE: PATIENT ONE: SEVENTY-EIGHT HOURS; PATIENT TWO: ONE HUNDRED TWENTY-EIGHT HOURS; PATIENT THREE: SIX, TWENTY-TWO, SEVENTEEN AND ELEVEN HOURS. IN EACH CIRCUMSTANCE THE MEMBRANES WERE REPLACED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECMO 1500 ECMO MEMBRANE DTZ MEDTRONIC INC. 1500 *

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR