BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE

    MDR report key: 3090584 · Received May 2, 2013

    Report

    Report Number
    1416980-2013-11149
    Event Type
    Death
    Date Received
    May 2, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 15, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REVIEW OF THE DEVICE HISTORY AND SERVICE HISTORY REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A PATIENT THAT PASSED AWAY COINCIDENT WITH DIANEAL THERAPY. THE NURSE REPORTED THE PATIENT WAS HOSPITALIZED FOR HAVING A STROKE (DATE NOT REPORTED). ON THE DAY OF ADMISSION, THE PATIENT'S FAMILY DECIDED TO WITHDRAW PERITONEAL DIALYSIS (PD) THERAPY DUE TO THE PATIENT'S STATUS. THE PD NURSE STATED THE PATIENT HAD A SIGNIFICANT CARDIAC HISTORY AND THEN PROCEEDED IN EXPLAINING THAT SHE WOULD NOT OFFER ANY ADDITIONAL INFORMATION REGARDING THE PATIENT AND THE EVENTS LEADING TO THE DEATH. NO ADDITIONAL INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192290 HOMECHOICE HOMECHOICE FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death| H