BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-CAL

    MDR report key: 86115 · Received April 16, 1997

    Report

    Report Number
    2124837-1997-00007
    Event Type
    Malfunction
    Date Received
    April 16, 1997
    Date of Event
    March 17, 1997
    Report Date
    April 16, 1997
    Manufacturer
    MEDTRONIC BIO-MEDICUS, INC.
    Product Code
    DWJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A BYPASS PROCEDURE, AND TOWARDS THE END OF THE CASE, THE PERFUSIONIST ATTEMPTED TO TURN THE UNIT SWITCH TO ON, WHILE ADMINISTERING A DOSE OF CARDIOPLEGIA. THE DEVICE INDICATED THE MESSAGE "ADD WATER." PERFUSIONIST FELT THAT THERE WAS ADEQUATE WATER IN THE DEVICE, AND THE MESSAGE WAS IN ERROR. DEVICE WAS REPLACED WITH A SECOND UNIT, AND THE CASE WAS CONTINUED 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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other