BEUDAMED
    FDA Adverse Event Other Summary report: N

    DIALINES

    MDR report key: 254122 · Received December 10, 1999

    Report

    Report Number
    MW1017709
    Event Type
    Other
    Date Received
    December 10, 1999
    Date of Event
    December 9, 1999
    Report Date
    December 9, 1999
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FJK
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    1 HR INTO TREATMENT, IT WAS NOTED THAT BLOOD WAS DRIPPING FROM PUMP AND AIR WAS IN BLOOD LINES. SYSTEM HAD ALARMED AND WAS SHUT DOWN. PUMP SEGMENT NOTED TO HAVE CRACK IN IT. REPLACED WITH DIFFERENT LOT #. PT RESTARTED ON DIALYSIS WITH NO PROBLEMS. SECOND OCCURRENCE TODAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIALINES DIALYZER BLOOD LINES FJK B. BRAUN MEDICAL, INC. * 99A2588

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other 1. DIALYSIS MACHINE BRAUN DIALOG.