BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE

    MDR report key: 3873413 · Received June 14, 2014

    Report

    Report Number
    1416980-2014-19041
    Event Type
    Death
    Date Received
    June 14, 2014
    Report Date
    May 20, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE PATIENT PASSED AWAY ON AN UNREPORTED DATE. THE INITIAL REPORTER DECLINED TO PROVIDE ADDITIONAL INFORMATION.SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND AN EVALUATION WAS PERFORMED TO INVESTIGATE THE REPORTED DEATH. A REVIEW OF THE SERVICE HISTORY RECORD WAS PERFORMED AND REVEALED NO FAILURES OR PROBLEMS THAT WERE THE SAME AS OR SIMILAR TO THE REPORTED EVENT. THE EVENT HISTORY LOG WAS REVIEWED AND REVEALED NO PROGRAMMING, MALFUNCTION, OR IIPV EVENTS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE PATIENT PASSING AWAY. THE DEVICE WAS DETERMINED TO MEET FUNCTIONAL AND ELECTRICAL PERFORMANCE SPECIFICATION REQUIREMENTS PER RITE (RETURNED INSTRUMENT TEST EVALUATION) TESTING. A SIMULATED THERAPY WAS COMPLETED WITH NO ISSUES NOTED AND ALL PRESSURES WERE FOUND TO BE CORRECT AND STABLE. AN INTERNAL AND EXTERNAL VISUAL INSPECTION REVEALED NO PROBLEMS RELATED TO THE REPORTED EVENT. UPON CONCLUSION OF THE INVESTIGATION, NO MALFUNCTION, ABNORMALITIES OR IIPV EVENTS WERE IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE PATIENT PASSING AWAY. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT PASSED AWAY COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF DEATH WAS NOT REPORTED. IT WAS NOT REPORTED WHETHER AN AUTOPSY WAS PERFORMED. IT WAS NOT REPORTED IF PERITONEAL DIALYSIS THERAPY WAS ONGOING UNTIL THE TIME OF DEATH. ADDITIONAL INFORMATION WAS REQUESTED, BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351747 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death