BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE PRO

    MDR report key: 3950859 · Received July 22, 2014

    Report

    Report Number
    1416980-2014-23686
    Event Type
    Death
    Date Received
    July 22, 2014
    Date of Event
    June 27, 2014
    Report Date
    June 27, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED AND AN EVALUATION WAS PERFORMED TO INVESTIGATE THE REPORTED EVENT. THE EVENT HISTORY LOG REVIEW SHOWED NO KEYSTROKES, PROGRAMMING, OR USE RELATED EVENTS THAT INDICATED AND/OR CONTRIBUTED TO THE REPORTED EVENT. A REVIEW OF THE SERVICE HISTORY REVEALED NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. DURING EVALUATION, THE DEVICE PASSED ELECTRICAL AND FUNCTIONAL TESTING AND WAS DETERMINED TO MEET PERFORMANCE SPECIFICATION REQUIREMENTS. INTERNAL AND EXTERNAL INSPECTION WAS PERFORMED AND NO ISSUES WERE NOTED. ALL PRESSURES WERE FOUND TO BE CORRECT AND STABLE. A SHORT SIMULATED THERAPY WAS PERFORMED WITH NO ISSUES NOTED. NO FAILURE OR MALFUNCTION OR IIPV EVENT WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE HOME PATIENT PASSING AWAY. THE DEVICE WILL BE SENT TO SERVICE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). 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). THE PATIENT PASSED AWAY AT HOME AT APPROXIMATELY 4:00 A.M. IT WAS REPORTED THE PATIENT WAS CONNECTED TO THE HC DEVICE AT THE TIME OF DEATH. THE CAUSE OF DEATH WAS REPORTED AS A HEART ATTACK. 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
    428748 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death DIANEAL LOW CALCIUM 1.5%, 2.5% AND 4.25%| EXTRANEAL SOLUTION