BEUDAMED
    FDA Adverse Event Other Summary report: N

    PERFUSION PACK, ECMO PACK, BAXTER PERFUSION SERVICES, AKRON

    MDR report key: 463034 · Received May 22, 2003

    Report

    Report Number
    1718850-2003-00011
    Event Type
    Other
    Date Received
    May 22, 2003
    Date of Event
    April 7, 2003
    Report Date
    May 22, 2003
    Manufacturer
    COBE CARDIOVASCULAR, INC.
    Product Code
    DWE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    DURING AN ECMO PROCEDURE, THE ARTERIAL PUMP HEAD TUBING WAS REPORTED TO HAVE RUPTURED. THE PROCEDURE WAS STOPPED IN ORDER TO CHANGE OUT THE DAMAGED TUBING. DURING THE PRODUCT CHANGE OUT, THE PT WAS SUPPORTED BY INCREASED MECHANICAL VENTILATION. THE ECMO PROCEDURE WAS RESTARTED AFTER APPROX 28 MINUTES WITH NO FURTHER COMPLICATIONS. THE PT WAS REMOVED FROM ECMO SUPPORT AND IS REPORTED TO BE DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERFUSION PACK, ECMO PACK, BAXTER PERFUSION SERVICES, AKRON CUSTOM PERFUSION PACK DWE COBE CARDIOVASCULAR, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other