BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFFINITY CP PUMP

    MDR report key: 2960616 · Received February 7, 2013

    Report

    Report Number
    MW5028945
    Event Type
    Injury
    Date Received
    February 7, 2013
    Date of Event
    December 23, 2012
    Report Date
    February 7, 2013
    Manufacturer
    MEDTRONIC
    Product Code
    KFM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT 1: PT ON V-V ECMO AWAITING LUNG TX SINCE (B)(6) 2012 AT 2035. ENTIRE ECMO CIRCUIT CHANGED OUT URGENTLY ON (B)(6) 2012 AT 0420 DUE TO SLIGHT DECREASE IN FLOWS FROM 4.51/MIN TO 3.41/MIN AND CLOT VISIBLE ON PUMP HEAD OUTFLOW. DECISION WAS MADE TO SWITCH ENTIRE CIRCUIT TO CARDIOHELP AS OPPOSED TO JUST A HEAD REPLACEMENT. PT RECEIVED DOUBLE LUNG TX ON (B)(6)AND WAS SUCCESSFULLY WEANED FROM ECMO ON (B)(6). EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52011 AFFINITY CP PUMP ECMO PUMP KFM MEDTRONIC

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention OXYGENATOR FOR VV ECMO| USED IN CONJUNCTION W/MAQUET QUADROX D