BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE

    MDR report key: 3946223 · Received July 21, 2014

    Report

    Report Number
    1416980-2014-23433
    Event Type
    Death
    Date Received
    July 21, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 26, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). THE PATIENT WAS BORN ON AN UNSPECIFIED DATE IN 1933. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE SERVICE HISTORY REVEALED NO PREVIOUS SERVICE EVENTS THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT OF DEATH. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT DIED COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY ON THE HOMECHOICE (HC). THE PATIENT WAS HOSPITALIZED PRIOR TO DEATH FOR ANOTHER INDICATION. IT WAS REPORTED THE PATIENT HAD RESPIRATORY FAILURE BUT THIS WAS NOT MEDICALLY CONFIRMED. THE CAUSE OF DEATH WAS UNKNOWN. IT WAS REPORTED PD THERAPY WAS ONGOING AT THE HOSPITAL AS THE PATIENT WAS USING THE HOSPITAL¿S HC DEVICE, HOWEVER; IT IS UNKNOWN IF THE PATIENT WAS ON THE HC DEVICE AT THE TIME OF DEATH. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED, BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424792 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 Death 2.5% DIANEAL PD4 AMBUFLEX