BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CGH LUNDIA AKPHA 700 (PL-CU/1.3M)

    MDR report key: 34042 · Received June 18, 1996

    Report

    Report Number
    2243621-1996-00192
    Event Type
    Malfunction
    Date Received
    June 18, 1996
    Date of Event
    June 11, 1996
    Report Date
    June 14, 1996
    Manufacturer
    COBE LABORATORIES
    Product Code
    FJG
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NURSE REPORTED THAT 5-10 MIN INTO HEMODIALYSIS TREATMENT THE BLOOD LEAK ALARM ON THE MACHINE WENT OFF. THE DIALYSATE TESTED POSITIVE FOR A BLOOD LEAK. EBL >100CC. TREATMENT WAS DISCONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CGH LUNDIA AKPHA 700 (PL-CU/1.3M) DIALYZER FJG COBE LABORATORIES 6-0510-N11

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN