BEUDAMED
    FDA Adverse Event Summary report: N

    AFFINITY CP PUMP

    MDR report key: 3020834 · Received March 19, 2013

    Report

    Report Number
    MW5029464
    Date Received
    March 19, 2013
    Date of Event
    February 26, 2013
    Report Date
    March 19, 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

    PRIOR TO THIS INCIDENT, THE PT WAS BEING BATHED AND TURNED ON HER LEFT SIDE WITH NORMAL BLOOD FLOWS 2.5, 2.6 AND 1880 RPM AND STABLE HEMODYNAMICS. THE PT WAS TURNED BACK TO A SUPINE POSITION AND THE MEDTRONIC PUMP ALARMED INDICATING A "LOW FLOW ALARM." AT THAT POINT, THERE WAS NO FLOW (ATTEMPTING TO FLOW FROM 0, 0.4): THE RPMS WERE ADJUSTED, INCREASED AND DECREASED, WITHOUT ANY BLOOD FLOW CHANGES. ATER THESE ACTIONS THERE WAS STILL NO FORWARD FLOW. THE VENTILATOR SETTINGS WERE ADJUSTED, NURSING AND PHYSICIAN INTERVENTIONS ENSUED. I CALLED THE PERFUSION WORK ROOM FOR ASSISTANCE AND WORKED TO REPLACE THE PUMP AND/OR CIRCUIT. THE CIRCUIT WAS REPLACED WITH A CARDIOHELP DEVICE ((B)(4)) AT 1539. DATES OF USE: (B)(6) 2013 - (B)(6) 2013. REASON FOR USE: ECMO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113149 AFFINITY CP PUMP ECMO PUMP KFM MEDTRONIC 206208599

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention