BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-CAL

    MDR report key: 276810 · Received May 3, 2000

    Report

    Report Number
    2124837-2000-00007
    Event Type
    Malfunction
    Date Received
    May 3, 2000
    Date of Event
    April 4, 2000
    Report Date
    May 3, 2000
    Manufacturer
    MEDTRONIC BIO-MEDICUS, INC.
    Product Code
    DWJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING THE BYPASS PROCEDURE, THE BIO-CAL MODEL 370 HEATER/COOLER, DISPLAYED A "WATCH DOG" ERROR. THE PERFUSIONIST CHANGED OUT THE UNIT TO CONTINUE THE CASE WITH NO EFFECT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIO-CAL CARDIOPULMONARY BYPASS TEMPERATURE CONTROLLER DWJ MEDTRONIC BIO-MEDICUS, INC. 370 AK0297

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other