BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE

    MDR report key: 3920115 · Received July 8, 2014

    Report

    Report Number
    1416980-2014-21854
    Event Type
    Death
    Date Received
    July 8, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 13, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED FOR EVALUATION. A REVIEW OF THE EVENT HISTORY LOG DID NOT VERIFY THE REPORTED EVENT AND REVEALED THERE WERE NO KEYSTROKES, PROGRAMMING, USE RELATED OR IIPV EVENTS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. REVIEW OF SERVICE HISTORY DATA REVEALED PREVIOUS DEVICE SERVICING DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. ANALYSIS OF THE DEVICE PNEUMATIC SYSTEM REVEALED NO LEAK AND ALL PRESSURES WERE CORRECT & STABLE. A SHORT SIMULATED THERAPY WAS PERFORMED AND COMPLETED SUCCESSFULLY. THE DEVICE PASSED SEAL, PURGE & WET DISPOSABLE INTEGRITY TESTS. RETURNED HOMECHOICE DEVICES RECEIVE A RETURNED INSTRUMENT TESTING EVALUATION (RITE). THIS EVALUATION INCLUDES FUNCTIONAL AND ELECTRICAL TESTING ON THE DEVICE. EXTERNAL/INTERNAL INSPECTION WAS PERFORMED AND PASSED. UPON CONCLUSION OF THE INVESTIGATION, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. 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 THE PATIENT¿S DEATH WAS UNKNOWN. IT WAS REPORTED THAT AN AUTOPSY WAS NOT PERFORMED. THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM AND DIED AT THE HOSPITAL. THE PD THERAPY HAD BEEN ONGOING, BUT THE PATIENT WAS IN THE PD CLINIC AND WAS NOT CONNECTED TO THE CYCLER AT THE ONSET OF SYMPTOMS. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398161 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death DIANEAL 1.5% AND 2.5% ULTRABAG| DIANEAL 1.5% AND 2.5% AMBUFLEX