BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE PRO

    MDR report key: 4183038 · Received October 17, 2014

    Report

    Report Number
    1416980-2014-36422
    Event Type
    Death
    Date Received
    October 17, 2014
    Date of Event
    September 21, 2014
    Report Date
    September 22, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND SERVICED BEFORE THE REPORT OF THE DEATH WAS KNOWN; THEREFORE, A COMPLETE EVALUATION WAS NOT PERFORMED. A REVIEW OF THE EVENT HISTORY LOG REVEALED NO FAILURE, MALFUNCTION, OR IIPV EVENTS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE SAMPLE ANALYSIS WAS NOT PERFORMED BECAUSE THE DEVICE WAS RECEIVED AND ROUTED TO SERVICE PRIOR TO THE PRODUCT ANALYSIS LAB BEING MADE AWARE OF ITS COMPLAINT STATUS. A REVIEW OF THE SERVICE HISTORY REVEALED NO PREVIOUS SERVICE EVENTS THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. RETURNED HOMECHOICE DEVICES RECEIVE A RETURNED INSTRUMENT TESTING EVALUATION (RITE). THIS EVALUATION INCLUDES FUNCTIONAL AND ELECTRICAL TESTING ON THE DEVICE. THERE WAS NO NON-CONFORMING PRODUCT IDENTIFIED RELATED TO THE REPORTED PROBLEM. THERE IS NO EVIDENCE THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED PATIENT DEATH. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT DIED COINCIDENT WITH PERITONEAL DIALYSIS THERAPY. THE PATIENT DIED AT HOME WHILE CONNECTED TO THE HOMECHOICE MACHINE. THE CAUSE OF DEATH WAS REPORTED TO BE RELATED TO THE PATIENT¿S HEART, KIDNEYS, AND LUNGS. AN AUTOPSY WAS PERFORMED. THE PATIENT WAS HOSPITALIZED PRIOR TO DEATH FOR AN UNRELATED ISSUE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661625 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death DIANEAL 1.5% SINGLEBAG (LOW CALCIUM).