BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE

    MDR report key: 4220149 · Received November 3, 2014

    Report

    Report Number
    1416980-2014-38443
    Event Type
    Death
    Date Received
    November 3, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 8, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED FOR EVALUATION. AN EXTERNAL AND INTERNAL INSPECTION WAS PERFORMED AND THE DEVICE PASSED. A REVIEW OF THE DEVICE EVENT HISTORY LOGS REVEALED NO SYSTEM ERRORS, ANOMALIES, HARDWARE DEVICE FAILURES OR INTRAPERITONEAL VOLUME IIPV EVENTS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY. 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. A SHORT SIMULATED THERAPY WAS COMPLETED SUCCESSFULLY. REVIEW OF THE DEVICE SERVICE HISTORY REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED 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 CARDIO-PULMONARY ARREST. IT WAS UNKNOWN IF THE PATIENT WAS CONNECTED TO THE HOMECHOICE DEVICE AT THE TIME OF DEATH. 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
    701066 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death DIANEAL 1.5% SINGLEBAG