BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIO-CONSOLE

    MDR report key: 107235 · Received July 18, 1997

    Report

    Report Number
    2124837-1997-00015
    Event Type
    Death
    Date Received
    July 18, 1997
    Date of Event
    June 16, 1997
    Report Date
    July 15, 1997
    Manufacturer
    MEDTRONIC BIO-MEDICUS, INC.
    Product Code
    DWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HOSP REPORTED THAT A 46 YEAR PT UNDERWENT EMERGENCY BYPASS FOLLOWING A SERIOUS BICYCLE ACCIDENT WHICH RESULTED IN A TRAUMATIC THORACIC ANEURYSM. AIR WAS NOTED ENTERING THE BIO-PUMP BY WHAT WAS BELIEVED TO BE A FAILING SUTURE AROUND THE CANNULA. HOSP PERSONNEL INDICATED THAT THE BIO-PUMP PUMPED AIR ORIGINATING FROM THE SUTURE SITE. THE DECISION WAS MADE TO TERMINATE THE CASE. THE PT EXPIRED.

    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 46 YR Death