BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-CONSOLE

    MDR report key: 100272 · Received June 17, 1997

    Report

    Report Number
    2124837-1997-00013
    Event Type
    Malfunction
    Date Received
    June 17, 1997
    Date of Event
    May 19, 1997
    Report Date
    June 17, 1997
    Manufacturer
    MEDTRONIC BIO-MEDICUS, INC.
    Product Code
    DWA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    HOSP REPORTED THAT NEAR THE END OF A CASE, (DURING REWARMING OF THE PT) THE FLOW DISPLAY SPIKED. THERE WAS NO CHANGE IN RPM'S AND THE RESERVOIR WAS FILLING, HOWEVER, THE BIO-CONSOLE DID NOT APPEAR TO BE PUMPING. THE PT WAS OFF BYPASS FOR 2 TO 3 MINUTES UNTIL AN EMERGENCY HANDCRANK WAS IN PLACE. PT LATER EXPIRED, HOWEVER, AS PER THE ASSISTANT DIRECTOR OF SURGICAL SERVICE, PT DEATH WAS RELATED TO OTHER COMPLICATIONS, AND NOT TO THIS INCIDENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other