BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBE VPCML PLUS WITH SAT/HCT FITTING

    MDR report key: 134055 · Received November 21, 1997

    Report

    Report Number
    1718850-1997-00019
    Event Type
    Injury
    Date Received
    November 21, 1997
    Date of Event
    September 8, 1997
    Report Date
    September 9, 1997
    Manufacturer
    COBE CARDIOVASCULAR, INC.
    Product Code
    DTZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IMMEDIATELY AFTER BYPASS START, THE PUMP STOPPED RUNNING BECAUSE OF A PRESSURE ALARM. THE PERFUSIONIST INSPECTED THE CIRCUIT AND VPCML MEMBRANE AND FOUND VISIBLE CLOTTING IN THE ARTERIAL FILTER, THE RESERVOIR AND THE INLET OF THE 1/3 VPCML MEMBRANE COMPARTMENT. THEY CLAMPED OUT THE 1/3 VPCML MEMBRANE COMPARTMENT AND RAN ON THE 2/3 VPCML MEMBRANE COMPARTMENT. THEY ALSO CHANGED OUT THE ARTERIAL FILTER AND HEMOCONCENTRATOR, NEITHER OF WHICH WERE COBE PRODUCTS. ALTHOUGH THEY COULD FINISH THE PROCEDURE, IT WAS REPORTED TO BE DIFFICULT TO GO OFF BYPASS, BECAUSE OF THE "INADEQUATE PERFUSION". INFO RECEIVED ON 9/11/97 INDICATED THAT THE PT HAD EXTRACORPOREAL CIRCULATION-RELATED MYOCARDIAL PROBLEMS AND WAS IN "BAD CONDITION".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBE VPCML PLUS WITH SAT/HCT FITTING OXYGENATOR DTZ COBE CARDIOVASCULAR, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Other