BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE

    MDR report key: 4130694 · Received September 30, 2014

    Report

    Report Number
    1416980-2014-33949
    Event Type
    Death
    Date Received
    September 30, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 5, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL 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 SERVICE HISTORY AND THE EVENT HISTORY LOG WAS PERFORMED. THE REVIEW OF SERVICE HISTORY DID NOT IDENTIFY ANY PREVIOUS SERVICING EVENTS THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE OF PATIENT PASSING AWAY. REVIEW OF THE DEVICE LOGS DID NOT REVEAL ANY ISSUES THAT COULD BE RELATED TO THE REPORTED ISSUE. THERE WERE NO KEYSTROKES, NO DEVICE FAILURE, MALFUNCTION, PROGRAMMING, USE RELATED OR IIPV (INCREASED INTRAPERITONEAL VOLUME) EVENTS THAT WOULD INDICATE AND/OR CONTRIBUTE TO THE REPORTED ISSUE. 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. AN EXTERNAL & INTERNAL INSPECTION WAS PERFORMED WHICH REVEALED NO ANOMALIES. THERE WAS NO EVIDENCE OF FLUID OR MOISTURE FOUND WITHIN THE DEVICE. PER PAL EVALUATION, THERE WAS NO FAILURE, MALFUNCTION OR IIPV 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT PASSED AWAY COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT WAS NOT HOSPITALIZED PRIOR TO DEATH. PD THERAPY WAS NOT ONGOING AT THE TIME OF DEATH. THE CAUSE OF DEATH WAS REPORTED AS UNKNOWN, BUT MAY HAVE BEEN FROM CARDIAC ARREST (NOT CONFIRMED). AN AUTOPSY WAS NOT PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED, BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607886 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Death DIANEAL 1.5% LOW CALCIUM SINGLEBAG