BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBE 4.1 BLOOD; CRYSTALLOID CARDIOPLEGIA DELIVERY SET

    MDR report key: 216031 · Received August 15, 1996

    Report

    Report Number
    1718850-1996-00001
    Event Type
    Malfunction
    Date Received
    August 15, 1996
    Date of Event
    July 12, 1996
    Report Date
    July 17, 1996
    Manufacturer
    COBE CARDIOVASCULAR, INC.
    Product Code
    DWF
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A COBE CARDIOPLEGIA SET WAS BEING USED TO ADMINISTER BLOOD CARDIOPLEGIA TO THE PATIENT WHEN THE USER NOTICED THAT THE BLOOD CARIDIOPLEGIA WAS LEAKING FROM A CONNECTION DISTAL TO THE CARDIOPLEGIA MODULE. THE BLOOD WAS DISCOVERED TO HAVE SPRAYED IN SMALL QUANTITIES ONTO SEVERAL OPERATING ROOM PERSONNEL, BUT NO ADVERSE PROBLEMS RESULTED FOR THE USERS. PATIENT BLOOD LOSS WAS ESTIMATED TO LOSS THAN 50CC AND NO PATIENT INJURY RESULTED. THE USER APPLIED A TIE BAND TO THE LEAKING CONNECTION AND THE CASE PROCEEDED WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBE 4.1 BLOOD; CRYSTALLOID CARDIOPLEGIA DELIVERY SET CARDIOPLEGIA DELIVERY SET DWF COBE CARDIOVASCULAR, INC. NA 05B0613

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other