BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE PRO

    MDR report key: 4120497 · Received September 26, 2014

    Report

    Report Number
    1416980-2014-33283
    Event Type
    Death
    Date Received
    September 26, 2014
    Date of Event
    August 30, 2014
    Report Date
    September 2, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND AN EVALUATION WAS PERFORMED. THE EVENT HISTORY LOG WAS REVIEWED AND REVEALED NO PROGRAMMING, MALFUNCTION, OR IIPV EVENTS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE PATIENT PASSING WAY. THE DEVICE WAS DETERMINED TO MEET FUNCTIONAL AND ELECTRICAL PERFORMANCE SPECIFICATION REQUIREMENTS PER RITE (RETURNED INSTRUMENT TEST EVALUATION) TESTING. AN INTERNAL AND EXTERNAL VISUAL INSPECTION REVEALED NO PROBLEMS RELATED TO THE REPORTED EVENT. A REVIEW OF THE DEVICE HISTORY REVEALED NO NONCONFORMITIES, FAILURES, REWORK OR DEVIATIONS THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. UPON CONCLUSION OF THE INVESTIGATION,THERE IS NO EVIDENCE THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT PASSED AWAY. THE CAUSE OF DEATH WAS UNKNOWN. THE PATIENT PASSED AWAY AT HOME WHILE CONNECTED TO THE HOMECHOICE DEVICE. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601291 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death DIANEAL 1.5% PD4, DIANEAL 2.5% PD4, EXTRANEAL