BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE

    MDR report key: 3073678 · Received April 23, 2013

    Report

    Report Number
    1416980-2013-10177
    Event Type
    Death
    Date Received
    April 23, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 30, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REVIEW OF THE DEVICE HISTORY AND SERVICE HISTORY REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY. THE DEVICE WAS RETURNED FOR EVALUATION. AN INTERNAL INVESTIGATION IS CURRENTLY UNDER WAY, HOWEVER HAS NOT YET BEEN COMPLETED. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW UP REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RECEIVED FOR EVALUATION. AN ELECTRICAL AND FUNCTIONAL TEST WERE BOTH PERFORMED ON THE DEVICE. NO FAILURES NOR MALFUNCTIONS WERE IDENTIFIED DURING TESTING, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A HOME PATIENT'S PERITONEAL DIALYSIS (PD) NURSE REPORTED THE PATIENT PASSED AWAY AT HOME, WHILE CONNECTED TO THE HOMECHOICE DEVICE. PER THE NURSE, THE PATIENT HAD JUST BEGUN THERAPY A HALF HOUR PRIOR TO DYING. THE PD NURSE BELIEVES THE PATIENT'S MEDICAL HISTORY WAS THE CONTRIBUTING FACTOR OF DEATH. ADDITIONAL INFORMATION WAS REQUESTED AND NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT. THIS IS REPORT 1 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173327 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death DIANEAL