BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-CONSOLE

    MDR report key: 93739 · Received May 21, 1997

    Report

    Report Number
    2124837-1997-00010
    Event Type
    Malfunction
    Date Received
    May 21, 1997
    Date of Event
    April 18, 1997
    Report Date
    May 20, 1997
    Manufacturer
    MEDTRONIC BIO-MEDICUS, INC.
    Product Code
    DWA
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HOSPITAL REPORTED THAT DURING A BYPASS PROCEDURE (LESS THAN ONE HOUR INTO CASE) WHILE USING THE ARIES CENTRIFUGAL PUMP AND PUMP ADAPTER ON THE BIO-CONSOLE, A LOUD GRINDING NOISE WAS HEARD. THE PERFUSIONIST REMOVED THE ARIES PUMP AND ADAPTER AND SAID THAT THE MAGNET ON THE BIO-CONSOLE WAS NOT ROTATING. THE BIO-CONSOLE WAS REPLACED WITH A SECOND UNIT TO CONTINUE CASE WITH NO EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIO-CONSOLE CARDIOPULMONARY BYPASS PUMP SPEED CONTROL DWA MEDTRONIC BIO-MEDICUS, INC. 540 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other