BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE

    MDR report key: 3830286 · Received May 23, 2014

    Report

    Report Number
    1416980-2014-16798
    Event Type
    Death
    Date Received
    May 23, 2014
    Report Date
    May 1, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    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). AS THE DEVICE WAS NOT LINKED TO THE REPORTED DEATH UNTIL AFTER THE DEVICE HAD BEEN SERVICED, A COMPLETE DEVICE ANALYSIS COULD NOT BE PERFORMED. HOWEVER, 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 PROBLEM. A REVIEW OF THE DEVICE HISTORY REVEALED NO NONCONFORMITIES, FAILURES, 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

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT WHO PERFORMED THERAPY WITH A HOMECHOICE DEVICE (HC) PASSED AWAY. THE CAUSE OF DEATH WAS UNKNOWN. IT WAS REPORTED THAT THE PATIENT DIED SUDDENLY WHILE WASHING HIS CAR. IT WAS UNKNOWN IF THERAPY WAS ONGOING UNTIL THE TIME OF DEATH. IT IS UNKNOWN IF AN AUTOPSY WAS PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307687 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death DIANEAL PD SOLUTIONS AND EXTRANEAL