BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE

    MDR report key: 3221129 · Received July 11, 2013

    Report

    Report Number
    1416980-2013-18019
    Event Type
    Death
    Date Received
    July 11, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 17, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS EVALUATED AND THERE WAS NO FAILURE OR MALFUNCTION IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE PATIENT DEATH. A DEVICE HISTORY REVIEW AND SERVICE HISTORY REVIEW WAS COMPLETED AND THERE WERE NO ISSUES NOTED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION, OR IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A HOME PATIENT THAT PASSED AWAY. THE CAUSE OF DEATH WAS REPORTED TO BE A HEART ATTACK. THE PATIENT EXPERIENCED A HEART ATTACK, WAS ADMITTED TO THE HOSPITAL AND PASSED AWAY THE SAME DAY. TREATMENT AT THE HOSPITAL WAS NOT REPORTED. THE PATIENT'S NURSE REFUSED TO PROVIDE ANY ADDITIONAL DETAILS RELATED TO THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320507 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death| H DIANEAL 2.5%| EXTRANEAL 7.5%| DIANEAL 1.5%