BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE AUTOMATED PD SYSTEM 115 VOLT

    MDR report key: 277268 · Received May 12, 2000

    Report

    Report Number
    1423500-2000-00606
    Event Type
    Death
    Date Received
    May 12, 2000
    Date of Event
    March 31, 2000
    Report Date
    April 13, 2000
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL (HCP) OF HOME PT (HP) REPORTED THE HP DIED WHILE USING THE HOMECHOICE CYCLER FOR APD THERAPY. HCP RELATES THAT ON 03/30/2000, THE HP RECEIVED A CADAVER KIDNEY TRANSPLANT. PRIOR TO KIDNEY TRANSPLANTATION, THE HP HAD USED THE HOMECHOICE CYCLER FOR APD THERAPY AT HOME EVERY DAY, PERFORMING 1 HI-DOSE DAY EXCHANGE OF 600MLS AND 5 NIGHT EXCHANGES OF 1400MLS WITH A LAST FILL VOLUME OF 600MLS. HCP RELATES THAT THE HP WAS PLACED BACK ON THE HOMECHOICE CYCLER POST-TRANSPLANTATION WHILE STILL HOSPITALIZED, AS THE HP WAS HYPERKALEMIC AND HAD TUBULAR NECROSIS WITH NO URINE OUTPUT. HCP RELATES THAT ON 03/31/2000, AT 8:38AM DURING APD THERAPY, THE HP EXPERIENCED CARDIO-RESPIRATORY DISTRESS. THE HCP STATES IT WAS SUSPECTED THE HP HAD A RENAL ARTERY THROMBUS AND PULMONARY EMBOLISM. THE HCP RELATES THE HP'S CHEST WAS OPENED UP; HOWEVER, AFTER HAVING CODED FOR 1 HOUR THE HP WAS NOT ABLE TO BE RESUSCITATED AND AT APPROX 9:30AM WAS PRONOUNCED DEAD. HCP FURTHER RELATES THAT AN AUTOPSY WAS PERFORMED AND THE PRELIMINARY RESULTS WERE INCONCLUSIVE. THE HCP FROM THE DIALYSIS CENTER STATES THEY DO NOT ATTRIBUTE THE HP'S DEATH TO THE HOMECHOICE CYCLER AND THAT THERE IS NO ALLEGED FAILURE OF THE HOMECHOICE CYCLER. FOLLOW-UP WITH THE HCP FROM THE HOSP'S RISK MANAGEMENT DEPT REVEALS THERE IS NO ALLEGED FAILURE OF THE HOMECHOICE CYCLER; HOWEVER, THEY REQUEST THAT BAXTER PERFORM AN EVALUATION OF THE HOMECHOICE TO MAKE CERTAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SYSTEM 115 VOLT HOMECHOICE FKX BAXTER HEALTHCARE CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Death