BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE

    MDR report key: 3242515 · Received July 23, 2013

    Report

    Report Number
    1416980-2013-19427
    Event Type
    Death
    Date Received
    July 23, 2013
    Date of Event
    June 15, 2013
    Report Date
    June 28, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CMPLNT-(B)(4) IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED FOR EVALUATION. THE DEVICE PASSED RETURNED INSTRUMENT ELECTRICAL AND FUNCTIONAL TESTING. A REVIEW OF THE EVENT LOG, SERVICE HISTORY AND DEVICE HISTORY REVEALED NO FAILURES OR MALFUNCTIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT OF THE PATIENT PASSING AWAY. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    THIS IS A REPORT FROM A NURSE OF A HOME PATIENT (HP) THAT PASSED AWAY. THE PATIENT WAS NOT CONNECTED TO THE HOMECHOICE DEVICE AT THE TIME OF DEATH. ATTEMPTS HAVE BEEN MADE TO MAKE CONTACT WITH THE NURSE, BUT HAVE BEEN UNSUCCESSFUL. THE CAUSE OF THIS PATIENT'S DEATH IS UNKNOWN. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343139 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death