BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-CONSOLE

    MDR report key: 89938 · Received May 8, 1997

    Report

    Report Number
    2124837-1997-00008
    Event Type
    Malfunction
    Date Received
    May 8, 1997
    Date of Event
    April 4, 1997
    Report Date
    May 6, 1997
    Manufacturer
    MEDTRONIC BIO-MEDICUS, INC.
    Product Code
    DWA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PERFUSIONIST REPORTED THAT TWO HOURS INTO A BYPASS CASE, THE DEVICE'S MOTOR RPM'S DROPPED FROM 2500 TO 1000. THE PRESSURE APPEARED TO HAVE ALSO DROPPED, HOWEVER, CIRCUIT FLOW DISPLAY MAINTAINED 6 L/M. DEVICE WAS REMOVED FROM THE CIRCUIT, AND REPLACED WITH A BACK-UP UNIT. CASE WAS CONTINUED WITH NO FURTHER PROBLEMS. THE PT WAS VERY ILL, AND IT WAS A DIFFFICULT CASE, HOWEVER, SHE DID NOT FEEL THE PT'S CONDITION WAS DUE TO THE DEVICE INCIDENT.

    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