BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE

    MDR report key: 3944993 · Received July 18, 2014

    Report

    Report Number
    1416980-2014-23357
    Event Type
    Death
    Date Received
    July 18, 2014
    Date of Event
    June 21, 2014
    Report Date
    June 25, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS MANUFACTURED ON AN UNSPECIFIED DATE IN JAN 2011. THE DEVICE WAS EVALUATED BY THE BAXTER PRODUCT ANALYSIS LABORATORY (PAL). A REVIEW OF THE SERVICE HISTORY REVEALED NO PREVIOUS FAILURES/PROBLEMS SAME AS OR SIMILAR TO THE CURRENT PROBLEM, NO PARTS REPLACED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE PATIENT PASSING AWAY. A REVIEW OF THE EVENT HISTORY LOG REVEALED NO KEYSTROKES, PROGRAMMING, OR USE RELATED EVENTS THAT WOULD INDICATE AND/OR CONTRIBUTE TO THE PATIENT PASSING AWAY. THE DEVICE WAS TESTED AND PASSED BOTH THE HOMECHOICE RETURN INSTRUMENT TEST/ EVALUATION (RITE) FUNCTIONAL TEST AND THE RITE ELECTRICAL TEST. THE DEVICE WAS DETERMINED TO MEET FUNCTIONAL AND ELECTRICAL PERFORMANCE SPECIFICATION REQUIREMENTS. A VISUAL INSPECTION WAS PERFORMED WHICH REVEALED NO ANOMALIES. 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 SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED FOR EVALUATION. UPON COMPLETION OF BAXTER'S INVESTIGATION, IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT PASSED AWAY COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. IT WAS REPORTED THAT THE PATIENT WAS NOT HOSPITALIZED PRIOR TO THE TIME OF DEATH. IT WAS REPORTED THAT PERITONEAL DIALYSIS (PD) THERAPY WAS ONGOING PRIOR TO DEATH. IT WAS REPORTED THAT THE PATIENT WAS PERFORMING AUTOMATED PERITONEAL DIALYSIS (APD) AND WAS USING A DEVICE OF THEIR OWN PRIOR TO DEATH. IT WAS UNKNOWN IF THE PATIENT WAS CONNECTED TO THE BAXTER DEVICE PRIOR TO DEATH. THE CAUSE OF DEATH WAS NOT REPORTED AND 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
    422044 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death DIANEAL 1.5% AND 2.5% SINGLEBAG PD2