BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE

    MDR report key: 3914343 · Received July 3, 2014

    Report

    Report Number
    1416980-2014-21596
    Event Type
    Death
    Date Received
    July 3, 2014
    Report Date
    June 10, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED TO BAXTER HEALTHCARE FOR FURTHER INVESTIGATION. A REVIEW OF THE SERVICE HISTORY REVEALED NO PREVIOUS SERVICE EVENTS THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED PROBLEM. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT (PT), WHO PERFORMED PD THERAPY WITH A HOMECHOICE (HC) DEVICE, PASSED AWAY DUE TO AN UNKNOWN CAUSE. IT WAS NOT REPORTED WHETHER THE PT WAS HOSPITALIZED PRIOR TO DEATH. IT WAS NOT REPORTED WHETHER THE PT WAS CONNECTED TO THE HC AT THE TIME OF DEATH OR IF PD THERAPY WAS ONGOING UNTIL THE TIME OF DEATH. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389558 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 Death DIANEAL PD4, 4.25% AMBUFLEX| DIANEAL PD4, 2.5% AMBUFLEX| DIANEAL PD4, 1.5% AMBUFLEX| DIANEAL PD4, 1.5% ULTRABAG| DIANEAL PD4, 4.25% ULTRABAG| DIANEAL PD4, 2.5% ULTRABAG