BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRISMASATE

    MDR report key: 3821436 · Received May 20, 2014

    Report

    Report Number
    1051129-2014-00001
    Event Type
    Death
    Date Received
    May 20, 2014
    Date of Event
    April 19, 2014
    Report Date
    May 16, 2014
    Manufacturer
    GAMBRO DAYTONA
    Product Code
    KPO
    PMA / PMN Number
    K013448
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRISMASATE INVOLVED IN THIS INCIDENT WAS DISCARDED AND NOT AVAILABLE FOR INVESTIGATION.

    Description of Event or Problem · 1

    A PATIENT WHO WAS SUFFERING FROM SEPTIC SHOCK, RESPIRATORY FAILURE AND AKI WAS UNDERGOING CONTINUOUS RENAL REPLACEMENT THERAPY ON A PRISMAFLEX MACHINE WITH A PRISMAFLEX M 150 FILTER SET. THE PATIENT HAD A SUDDEN DECREASE IN HEART RATE AT WHICH TIME THE NURSE ALSO IDENTIFIED THE VENOUS LINE ON THE FILTER SET WAS DISCONNECTED FROM THE PATIENT¿S ACCESS CATHETER. THE PATIENT HAD A CARDIAC ARREST; BECAUSE OF THE DO NOT RESUSCITATE STATUS, NO RESUSCITATION WAS ATTEMPTED AND THE PATIENT EXPIRED. AT THE TIME OF THE TREATMENT, THE PATIENT WAS BEING INTUBATED WITH MECHANICAL VENTILATION AND RECEIVING VASOPRESSOR SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300440 PRISMASATE DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) KPO GAMBRO DAYTONA BGK 2/0 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death PRISMAFLEX PA7320 - PRISMAFLEX M150 LOT 14A2103G