BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE

    MDR report key: 2991426 · Received March 6, 2013

    Report

    Report Number
    1416980-2013-05418
    Event Type
    Death
    Date Received
    March 6, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 9, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RETURNED TO THE BAXTER PRODUCT ANALYSIS LAB FOR EVALUATION. UPON COMPLETION OF THE EVALUATION OR IF ADDITIONAL INFORMATION RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOMECHOICE DEVICE WAS RETURNED AND EVALUATED BY THE BAXTER PRODUCT ANALYSIS LABORATORY (PAL). THE DEVICE PASSED BOTH THE HOMECHOICE RITE (RETURNED INSTRUMENT TEST EVALUATION) ELECTRICAL TEST AND THE HOMECHOICE RITE FUNCTIONAL TEST. THE DEVICE WAS DETERMINED TO MEET PERFORMANCE SPECIFICATION REQUIREMENTS PER RITE TESTING. THE PAL EVALUATED THE DEVICE AND NO FAILURE NOR MALFUNCTION WAS IDENTIFIED, THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE HOME PATIENT PASSING AWAY. THEREFORE THE CONDITION COULD NOT BE CONFIRMED, NOR COULD THE CAUSE BE DETERMINED. ADDITIONAL INFORMATION: A REVIEW OF THE DEVICES LOGS REVEALED NO FAILURE, MALFUNCTION OR IIPV (INCREASED INTRA-PERITONEAL VOLUME) EVENTS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY. A SERVICE HISTORY REVIEW REVEALED NO PREVIOUS SERVICE EVENTS WERE RELATED TO THE REPORTED CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT DIED FROM AN UNKNOWN CAUSE WHILE IN THE HOSPITAL. ON AN UNREPORTED DATE, THE PATIENT BEGAN PERITONEAL DIALYSIS (PD) THERAPY WITH DIANEAL PD4 AMBUFLEX SOLUTION INTRAPERITONEALLY (IP), (TOTAL FILL VOLUME, FREQUENCY, AND LOT NUMBERS NOT REPORTED). ON AN UNKNOWN DATE, APPROXIMATELY ONE MONTH PRIOR TO THIS REPORT, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR "SOMETHING RESPIRATORY RELATED". THE ADMITTING HOSPITAL DIAGNOSIS WAS NOT OFFICIALLY CONFIRMED. TREATMENTS FOR AND THE OUTCOME OF THE EVENT WERE NOT REPORTED. IT WAS UNKNOWN IF THE PATIENT WAS RECEIVING PD THERAPY VERSUS HEMODIALYSIS DURING THE HOSPITALIZATION. ON AN UNSPECIFIED DATE, THE PATIENT PASSED AWAY WHILE IN THE HOSPITAL. THE CAUSE OF DEATH WAS UNKNOWN. IT WAS UNKNOWN IF THE PATIENT WAS CONNECTED TO THE HOMECHOICE MACHINE OR RECEIVING DIANEAL PD4 SOLUTION AT THE TIME OF DEATH. NO FURTHER INFORMATION REGARDING THE PATIENT DEATH WAS KNOWN. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95653 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Death DIANEAL PD4 AMBUFLEX