BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE PRO

    MDR report key: 3831608 · Received May 25, 2014

    Report

    Report Number
    1416980-2014-16969
    Event Type
    Death
    Date Received
    May 25, 2014
    Date of Event
    April 13, 2014
    Report Date
    April 30, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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 RETURNED TO BAXTER AND AN EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE LOGS REVEALED NO ABNORMALITIES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. A SERVICE HISTORY REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS NOTED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT DURING THE SERVICE OF THIS DEVICE. INTERNAL AND EXTERNAL INSPECTION WAS PERFORMED AND NO ISSUES WERE NOTED. ALL PRESSURES WERE FOUND TO BE CORRECT AND STABLE. A SIMULATED THERAPY WAS PERFORMED AND COMPLETED SUCCESSFULLY. THE DEVICE PASSED BOTH THE HOMECHOICE RITE (RETURN INSTRUMENT TEST/EVALUATION) ELECTRICAL TEST AND THE HOMECHOICE RITE FUNCTIONAL TEST AND WAS DETERMINED TO MEET PERFORMANCE SPECIFICATION REQUIREMENTS. THERE WAS NO NON-CONFORMING PRODUCT IDENTIFIED RELATED TO THE REPORTED PROBLEM. THE DEVICE WILL BE SENT TO SERVICE. 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 WHO PASSED AWAY COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR AN UNKNOWN INDICATION APPROXIMATELY ONE WEEK PRIOR TO DEATH. THE CAUSE OF DEATH WAS UNKNOWN. IT WAS NOT REPORTED WHETHER PD THERAPY WAS ONGOING UNTIL THE TIME OF DEATH OR IF THE PATIENT PERFORMING THERAPY AT THE TIME OF DEATH. IT WAS UNKNOWN IF AN AUTOPSY WAS PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309726 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Death| H DIANEAL 1.5%, 2.5%, 4.25% AMBUFLEX PD4