BEUDAMED
    FDA Adverse Event Death Summary report: N

    GAMCATH

    MDR report key: 3499901 · Received December 4, 2013

    Report

    Report Number
    3004367028-2013-00004
    Event Type
    Death
    Date Received
    December 4, 2013
    Date of Event
    August 30, 2013
    Report Date
    November 12, 2013
    Manufacturer
    GAMBRO DIALYSATOREN GMBH
    Product Code
    MPB
    PMA / PMN Number
    K040301
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD THE GAMCATH MC-GDHK-1315J DOLPHIN PROTECT WITH LOT NUMBER 2012-10-1817 SHOWS THAT THE CATHETER WAS MANUFACTURED IN ACCORDANCE TO SPECIFICATIONS. THE COMPLAINT HISTORY DID NOT SHOW ANY SIMILAR COMPLAINT FOR THE USED LOT NUMBER. GAMBRO DOES NOT REGARD THE SUBMITTAL OF THIS REPORT AS AN ADMISSION OF CAUSATION OR LIABILITY.

    Description of Event or Problem · 1

    A PATIENT IN (B)(6) WAS HOSPITALIZED WITH SEPSIS AND WAS REPORTED TO BE CONFUSED AND ANXIOUS. WHEN THE PATIENT'S MEDICAL CONDITION BEGAN TO DETERIORATE, A TEMPORARY ACCESS CATHETER WAS INSERTED TO BE USED AS THE ACCESS SITE FOR CONTINUOUS RENAL REPLACEMENT THERAPY. WHEN THE NURSE CHECKED ON THE PATIENT, SHE FOUND HE HAD EXPIRED AND THE GAM CATH CATHETER HAD BEEN REMOVED FROM THE PATIENT'S VASCULATURE AND FOUND LYING ON THE FLOOR. THE FORENSICS¿ OPINION IS THE CAUSE OF DEATH WAS EXSANGUINATION RELATED TO REMOVAL OF THE ACCESS CATHETER AND THE PATIENT'S UNDERLYING MEDICAL CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627730 GAMCATH CATHETER, HEMODIALYSIS, NON-IMPLANTED MPB GAMBRO DIALYSATOREN GMBH GAMCATH MC-GDHK-1315 DOLPHIN PROTECT 2012-10-1817

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death