BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE PRO

    MDR report key: 3873429 · Received June 14, 2014

    Report

    Report Number
    1416980-2014-19036
    Event Type
    Death
    Date Received
    June 14, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 20, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED FOR EVALUATION. REVIEW OF THE DEVICE SERVICE HISTORY REVEALED NO PREVIOUS SERVICING EVENTS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE EXTERNAL/INTERNAL INSPECTION OF THE DEVICE DID NOT FIND ANY ISSUES. RETURNED HOMECHOICE DEVICES RECEIVE A RETURNED INSTRUMENT TESTING EVALUATION (RITE). THIS EVALUATION INCLUDES FUNCTIONAL AND ELECTRICAL TESTING ON THE DEVICE. THE DEVICE PASSED BOTH THE ELECTRICAL AND FUNCTIONAL TESTING. ANALYSIS OF THE DEVICE PNEUMATIC SYSTEM REVEALED NO LEAKS AND ALL PRESSURES WERE CORRECT AND STABLE. A SHORT SIMULATED THERAPY WAS PERFORMED SUCCESSFULLY. UPON CONCLUSION OF THE EVALUATION, THE DIRECT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. A REVIEW OF THE EVENT HISTORY LOG WAS PERFORMED AND REVEALED NO DEVICE FAILURE OR MALFUNCTION THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED PROBLEM. HOWEVER, AN EVENT INVOLVING AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) WAS RECORDED IN THE THERAPY LOG (REPORTED THROUGH REPORT NUMBER 1416980-2014-21393). THIS COULD HAVE POTENTIALLY CAUSED OR CONTRIBUTED TO THE REPORTED EVENT; HOWEVER, THE CAUSE OF DEATH COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT (PT) WHO PERFORMED THERAPY WITH A HOMECHOICE DEVICE (HC) PASSED AWAY. THE CAUSE OF DEATH WAS REPORTED TO BE CARDIAC FAILURE. THE PT WAS HOSPITALIZED TWO MONTHS PRIOR TO DEATH FOR HEART COMPLICATIONS. IT WAS UNKNOWN IF PD THERAPY WAS ONGOING UNTIL THE TIME OF DEATH OR IF THE PT WAS CONNECTED TO THE HC DEVICE AT THE TIME OF DEATH. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351777 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death| H DIANEAL PD4 1.5% AMBUFLEX, 2.5% AND 4.25% ULTRABAG