BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE

    MDR report key: 3872659 · Received June 13, 2014

    Report

    Report Number
    1416980-2014-18917
    Event Type
    Death
    Date Received
    June 13, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 21, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT 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. 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 ALL PRESSURES WERE CORRECT AND STABLE. A SHORT SIMULATED THERAPY WAS PERFORMED SUCCESSFULLY. A REVIEW OF THE SERVICE HISTORY REVEALED NO PREVIOUS SERVICE EVENTS THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED PROBLEM. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A PERITONEAL DIALYSIS (PD) PATIENT WHO PASSED AWAY. ON AN UNKNOWN DATE, THE PATIENT WAS HOSPITALIZED DUE TO A HEART ATTACK AND SUBSEQUENTLY PASSED AWAY. THE CAUSE OF DEATH WAS REPORTED TO BE DUE TO CARDIAC ARREST. IT WAS UNKNOWN IF THERAPY WAS ONGOING AT THE TIME OF DEATH. IT WAS UNKNOWN IF AN AUTOPSY WAS PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349004 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death| H DIANEAL