BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-PUMP

    MDR report key: 121874 · Received September 17, 1997

    Report

    Report Number
    2124837-1997-00019
    Event Type
    Malfunction
    Date Received
    September 17, 1997
    Date of Event
    August 8, 1997
    Report Date
    September 17, 1997
    Manufacturer
    MEDTRONIC BIO-MEDICUS, INC.
    Product Code
    KFM
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    POST SURGICAL CIRCULATORY SUPPORT WAS INITIATED ON AUGUST 4,1997. BLOOD LEAKAGE WAS FOUND AT BASE OF OUTLET PORT ON AUGUST 7, 1997. THE CLINICIAN ATTEMPTED TO STOP LEAKAGE BY ADDING A TYRAP TO THE NOZZLE. LEAKAGE DID NOT STOP. THE DEVICE WAS REPLACED WITH ANOTHER BIO-PUMP TO CONTINUE WITH NO EFFECT TO THE PATIENT. THE PATIENT EXPIRED ON AUGUST 13, 1997. HOWEVER, THE OCCURRENCE WAS UNRELATED TO THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIO-PUMP EXTRACORPOREAL CENTRIFUGAL BLOOD PUMP KFM MEDTRONIC BIO-MEDICUS, INC. BP-80 9609000595

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other