BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE PRO

    MDR report key: 3787321 · Received May 2, 2014

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    Report

    Report Number
    1416980-2014-14237
    Event Type
    Death
    Date Received
    May 2, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 8, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORTER: FACILITY NAME AND ADDRESS: (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED FOR EVALUATION BY THE BAXTER PRODUCT ANALYSIS LABORATORY (PAL). A REVIEW OF THE EVENT HISTORY RECORD DID NOT REVEAL ANY ISSUES THAT COULD BE RELATED TO THE REPORTED EVENT. THERE WERE NO KEYSTROKES, PROGRAMMING, USE RELATED OR IIPV (INCREASED INTRAPERITONEAL VOLUME) EVENTS THAT WOULD INDICATE AND/OR CONTRIBUTE TO THE REPORTED ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD AND SERVICE HISTORY WAS PERFORMED WITH NO ISSUES FOUND THAT COULD BE RELATED TO THE REPORTED EVENT. THE DEVICE WAS TESTED AND PASSED THE HOMECHOICE (HC) RETURN INSTRUMENT TEST/ EVALUATION (RITE) ELECTRICAL TEST. THE DEVICE WAS DETERMINED TO MEET ELECTRICAL PERFORMANCE SPECIFICATION REQUIREMENTS. THE DEVICE WAS TESTED AND FAILED THE HC RITE FUNCTIONAL TEST AND WAS DETERMINED NOT TO MEET PERFORMANCE SPECIFICATION REQUIREMENTS PER RITE FUNCTIONAL TESTING. THE DEVICE PASSED ALL TESTING PERFORMED IN PAL PERTAINING TO VOLUMETRIC AND TEMPERATURE ACCURACY. THE RITE FAILURE WAS NOT RELATED TO THE REPORTED ISSUE. PER PAL EVALUATION, THERE WAS NO FAILURE, MALFUNCTION OR IIPV (INCREASED INTRAPERITONEAL VOLUME) EVENT IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE OF PATIENT PASSING AWAY. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP 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 WAS HOSPITALIZED PRIOR TO DEATH FOR ANOTHER INDICATION. ON UNKNOWN DATE WHILE HOSPITALIZED PD THERAPY WAS DISCONTINUED AND HEMODIALYSIS WAS STARTED. THE CAUSE OF DEATH WAS REPORTED AS RESPIRATORY FAILURE. IT WAS REPORTED PD THERAPY WAS NOT ONGOING AT THE TIME OF DEATH. IT WAS UNKNOWN IF AN AUTOPSY WAS PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED, BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264556 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death DIANEAL PD4 LOW CALCIUM 2.5% SOLUTION