BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAMCATH

    MDR report key: 5978703 · Received September 26, 2016

    Report

    Report Number
    3004367028-2016-00007
    Event Type
    Injury
    Date Received
    September 26, 2016
    Date of Event
    August 15, 2016
    Report Date
    September 26, 2016
    Manufacturer
    GAMBRO DIALYSATOREN GMBH
    Product Code
    MPB
    PMA / PMN Number
    K100451
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    A PATIENT IN (B)(6) WITH LIVER FAILURE WAS UNDERGOING A MARS DIALYSIS TREATMENT VIA A GAM CATH MS-GDHK-1325 VASCULAR ACCESS CATHETER. APPROXIMATELY 30 MINUTES INTO TREATMENT THE CATHETER CRACKED IN ONE LUMEN RESULTING IN AN EXTERNAL BLOOD LEAK. THE TREATMENT WAS PLACED INTO RECIRCULATION WHILE A NEW CATHETER WAS INSERTED AND THEN TREATMENT CONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629754 GAMCATH CATHETER, HEMODIALYSIS, NON-IMPLANTED MPB GAMBRO DIALYSATOREN GMBH GAMCATH MS-GDHK-1325 DOLPHIN 2015-11-1859

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention