BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAMCATH

    MDR report key: 5721001 · Received June 13, 2016

    Report

    Report Number
    3004367028-2016-00006
    Event Type
    Malfunction
    Date Received
    June 13, 2016
    Date of Event
    May 1, 2016
    Report Date
    June 13, 2016
    Manufacturer
    GAMBRO DIALYSATOREN GMBH
    Product Code
    MPB
    PMA / PMN Number
    K100451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A CRITICALLY ILL PATIENT IN (B)(6) WITH LIVER FAILURE AND MULTIPLE COMPLICATIONS WAS UNDERGOING A DIALYSIS TREATMENT VIA A DOLPHIN GAM CATH VASCULAR ACCESS CATHETER. DURING TREATMENT, THE NURSE OBSERVED AN EXTERNAL BLOOD LEAK FROM THE CONNECTION AT THE CATHETER. THE DIALYSIS TREATMENT WAS STOPPED AND THE BLOOD IN THE EXTRACORPOREAL CIRCUIT WAS NOT RETURNED TO THE PATIENT RESULTING IN AN ESTIMATED BLOOD LOSS OF 200 ML. THE DATE OF THE EVENT IS UNKNOWN THEREFORE THE DATE IN THIS REPORT IS AN ESTIMATED DATE. REPORTEDLY, THE PATIENT DIED A FEW DAYS LATER SUBSEQUENTLY TO THE UNDERLYING MEDICAL CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374286 GAMCATH CATHETER, HEMODIALYSIS, NON-IMPLANTED MPB GAMBRO DIALYSATOREN GMBH GAMCATH MS-GDHK-1325 DOLPHIN 2015-09-1722

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention