BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2430724 · Received January 30, 2012

    Report

    Report Number
    1423500-2012-02036
    Event Type
    Death
    Date Received
    January 30, 2012
    Date of Event
    December 31, 2011
    Report Date
    January 10, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE NURSE, THE PATIENT HAD A HISTORY OF FREQUENT SEIZURE ACTIVITY DUE TO UNCONTROLLED BLOOD SUGARS. NO FURTHER INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT WAS NOT CONFIRMED. THE ROOT CAUSE FOR THE REPORTED EVENT WAS UNDETERMINED. THERE WAS NO DEVICE MALFUNCTION OR USE ERROR IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE NURSE CONFIRMED THAT THE PATIENT WAS CONNECTED TO THE HOMECHOICE DEVICE AT THE TIME OF THE EVENT. NO FURTHER INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER IS ATTEMPTING TO OBTAIN ADDITIONAL INFORMATION FROM THE REPORTER. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE AND IS A SPONTANEOUS REPORT BY A NURSE OF FATAL ASPHYXIATION. ON AN UNKNOWN DATE THE PATIENT BEGAN PERITONEAL DIALYSIS (PD) THERAPY USING DIANEAL PD4 AMBUFLEX TOTAL FILL 2 LITERS 3 EXCHANGES DAILY (LOT NUMBER NOT REPORTED) INTRAPERITONEALLY (IP) AND EXTRANEAL, TOTAL FILL VOLUME 1.5 TIMES 1 EXCHANGE IP FOR END STAGE RENAL DISEASE (ESRD). ON (B)(6) 2011, THE PATIENT EXPERIENCED ASPHYXIA, DESCRIBED AS STRANGULATION OF THE HOMECHOICE DEVICE TUBING WRAPPED AROUND THE PATIENT'S NECK. IT WAS NOT REPORTED IF THE PATIENT REQUIRED HOSPITALIZATION OR IF REMEDIAL THERAPY WAS RENDERED. ON THAT SAME DATE, THE PATIENT DIED. THE CAUSE OF DEATH WAS FATAL ASPHYXIA. THE OFFICIAL CAUSE OF DEATH ON THE DEATH CERTIFICATE WAS ASPHYXIA. THE PATIENT'S PD THERAPY WAS ONGOING AT THE TIME OF DEATH. AT THE TIME OF THIS REPORT, AN AUTOPSY WAS NOT PERFORMED. THE REPORTER STATED THAT THE EVENT OF DEATH WAS NOT RELATED TO PD THERAPY OR THE HOMECHOICE MACHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Death HOMECHOICE| EXTRANEAL| DIANEAL PD4 AMBUFLEX| INSULIN PUMP