BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTRA

    MDR report key: 513949 · Received February 20, 2004

    Report

    Report Number
    MW1031265
    Event Type
    Injury
    Date Received
    February 20, 2004
    Date of Event
    February 11, 2004
    Report Date
    February 13, 2004
    Manufacturer
    JOSTRA AB
    Product Code
    DWA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING CARDIOPULMONARY BYPASS; THE "ARTERIAL" PUMP STOPPED FUNCTIONING. THE PUMP WAS OPERATED MANUALLY. THE PUMP DISPLAY SHOWED "DIFF. ERR". THE PUMP WAS REPLACED WITH ANOTHER PUMP. THE MALFUNCTIONING PUMP WAS PLACED IN AN ALTERNATE HEART-LUNG MACHINE, AND FUNCTIONED NORMALLY. THE REPLACEMENT PUMP OPERATED NORMALLY, AND THE CASE PROCEEDED WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOSTRA PUMP HEAD (RPM) DWA JOSTRA AB 20-320 *

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Life Threatening