BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE PRO

    MDR report key: 4113600 · Received September 24, 2014

    Report

    Report Number
    1416980-2014-32985
    Event Type
    Death
    Date Received
    September 24, 2014
    Report Date
    August 27, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE LOGS REVEALED NO SYSTEM ERRORS, ANOMALIES, HARDWARE DEVICE FAILURES OR INCREASED INTRAPERITONEAL VOLUME (IIPV) EVENTS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY. DURING VISUAL INSPECTION, NO ISSUES WERE OBSERVED. THE POWER ON SELF-TEST WAS SUCCESSFULLY PERFORMED. ONE HOUR THERAPY WAS SUCCESSFULLY PERFORMED. THE DEVICE PASSED ALL CHECKS AND CALIBRATION TESTS SUCCESSFULLY DURING SERVICE. A REVIEW OF THE DEVICE HISTORY REVEALED NO NONCONFORMITIES, REWORK, OR DEVIATIONS THAT WOULD CAUSE OR CONTRIBUTE TO THE HOME PATIENT PASSING AWAY. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A PATIENT DEATH COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY ON THE HOMECHOICE (HC). IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED PRIOR TO DEATH. IT WAS UNKNOWN IF PD THERAPY WAS ONGOING UNTIL THE TIME OF DEATH. THE CAUSE OF DEATH WAS NOT REPORTED; HOWEVER THE CAREGIVER REPORTED IT WAS EXPECTED. 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
    595578 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death EXTRANEAL 7.5% SOLUTION