BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC CARDIOPULMONARY

    MDR report key: 1192207 · Received October 7, 2008

    Report

    Report Number
    MW5008578
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    September 16, 2008
    Report Date
    October 7, 2008
    Product Code
    DWA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BIOMEDICAL MODEL 560 CONSOLE MADE BY MEDTRONIC FAILED DURING CARDIOPULMONARY BYPASS. LOW LEVEL ALARM ACTIVATED CAUSING PUMP TO COAST, FLOW CEASED. TURNED OFF ALARMS, REACTIVATED CONSOLE, NOW FLOWS. HAND CRANKING PERFORMED UNTIL REPLACEMENT PUMP PUT INTO USE. CONTINUED WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC CARDIOPULMONARY BIOMEDICAL MODEL 560 CONSOLE DWA 560

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| S