BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE PRO

    MDR report key: 3911795 · Received July 3, 2014

    Report

    Report Number
    1416980-2014-21413
    Event Type
    Death
    Date Received
    July 3, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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. THE DEVICE PASSED BOTH THE HOMECHOICE RITE (RETURN INSTRUMENT TEST/EVALUATION) ELECTRICAL TEST AND THE HOMECHOICE RITE FUNCTIONAL TEST AND WAS DETERMINED TO MEET PERFORMANCE SPECIFICATION REQUIREMENTS PER RITE TESTING. AN INTERNAL AND EXTERNAL INSPECTION WAS PERFORMED AND FOUND NO ISSUES. AN EVALUATION OF THE DEVICE PNEUMATIC SYSTEM REVEALED NO LEAKS AND ALL PRESSURES WERE CORRECT AND STABLE. THE DEVICE PASSED SEAL, PURGE, AND WET DISPOSABLE INTEGRITY TESTS. A SHORT SIMULATED THERAPY WAS PERFORMED SUCCESSFULLY. THE DEVICE EVALUATION FOUND NO FAILURES OR MALFUNCTIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. A DEVICE HISTORY REVIEW FOUND NO PRIOR ISSUES THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. 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 REPORTED THE PATIENT WAS NOT HOSPITALIZED PRIOR TO DEATH. THE PATIENT WAS FOUND DECEASED AT HOME. THE CAUSE OF DEATH WAS REPORTED TO BE NATURAL CAUSES. IT WAS REPORTED THE PATIENT WAS PERFORMING PD THERAPY ON THE HC DEVICE AT THE TIME OF DEATH. 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
    391164 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death DIANEAL PD-4 2.5% AND 4.25% SOLUTIONS