BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE

    MDR report key: 3902585 · Received June 30, 2014

    Report

    Report Number
    1416980-2014-20854
    Event Type
    Death
    Date Received
    June 30, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 5, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP 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 EVENT. THE PRODUCT ANALYSIS LAB (PAL) EVALUATED THE DEVICE AND NO FAILURE OR MALFUNCTION WERE IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE PATIENT PASSING AWAY. A VISUAL INSPECTION WAS PERFORMED AND FOUND NO ISSUES. THE POWER ON SELF-TEST WAS SUCCESSFULLY PERFORMED. THE DEVICE PASSED ALL TESTS PER PROCEDURE. THE DEVICE WAS SERVICED MORE THAN 1 YEAR AGO THEREFORE A SERVICE HISTORY REVIEW WAS NOT PERFORMED AS PART OF THE COMPLAINT INVESTIGATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT WHO PERFORMED THERAPY WITH A HOMECHOICE DEVICE (HC) PASSED AWAY. THE PATIENT WAS HOSPITALIZED PRIOR TO DEATH. THE CAUSE OF DEATH REPORTED BY THE PATIENT¿S SPOUSE WAS ¿EVERYTHING STOPPED, HIS LEFT LEG WAS AMPUTATED, LAST FEW WEEKS BEFORE HIS PASSING, HIS OTHER LEG -TOES WERE TURNING BLACK QUITE QUICKLY¿. PD THERAPY WAS ONGOING UNTIL THE PATIENT DIED BUT IT WAS REPORTED THAT THE PATIENT WAS NOT ON THE HOMECHOICE DEVICE AT THE TIME OF DEATH. AN AUTOPSY WAS NOT PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380920 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Death| H DIANEAL 1.5%, 2.5% AND EXTRANEAL VIAFLEX