BEUDAMED
    FDA Adverse Event Death Summary report: N

    BICART

    MDR report key: 4840121 · Received June 11, 2015

    Report

    Report Number
    9616023-2015-00009
    Event Type
    Death
    Date Received
    June 11, 2015
    Date of Event
    May 21, 2015
    Report Date
    June 10, 2015
    Manufacturer
    GAMBRO LUNDIA AB
    Product Code
    KPO
    PMA / PMN Number
    K013724
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE BICART PRODUCT INVOLVED IN THIS INCIDENT WAS DISCARDED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, AN INVESTIGATION COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    A HOME DIALYSIS PATIENT IN (B)(6) WITH MULTIPLE CO-MORBIDITIES, INCLUDING CARDIAC DISEASE, HAD NOT FELT WELL FOR SEVERAL DAYS. HIS SYMPTOMS INCLUDED HALLUCINATIONS, SHORTNESS OF BREATH, AND A DEEP COUGH. DURING A HOME DIALYSIS TREATMENT THAT INCLUDED BICART, THE PATIENT CONTINUED TO COMPLAIN OF NOT FEELING WELL. THE PATIENTS' WIFE IMMEDIATELY STOPPED DIALYSIS WITHOUT RETURNING THE BLOOD AND DISCONNECTED HIM FROM THE DIALYSIS MACHINE. SEVERAL MINUTES LATER THE PATIENT BECAME UNRESPONSIVE AND CPR WAS INITIATED BY THE HOME DIALYSIS NURSE. EMERGENCY MEDICAL SERVICES WAS CALLED AND THEY TRANSPORTED THE PATIENT TO THE HOSPITAL WHERE HE WAS LATER PRONOUNCED DEAD. THE HOME DIALYSIS NURSE STATED THE CAUSE OF DEATH WAS FROM THE PATIENTS' UNDERLYING CARDIAC CONDITIONS AND NOT FROM THE DIALYSIS TREATMENT OR EQUIPMENT. NO AUTOPSY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382071 BICART KPO GAMBRO LUNDIA AB BICART 720G

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death