BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 3932832 · Received July 14, 2014

    Report

    Report Number
    1416980-2014-22567
    Event Type
    Death
    Date Received
    July 14, 2014
    Date of Event
    June 14, 2014
    Report Date
    June 19, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT (PT), WHO PERFORMED PD THERAPY WITH A HOMECHOICE (HC) DEVICE EXPERIENCED A MYOCARDIAL INFARCTION AND SUBSEQUENTLY PASSED AWAY DUE TO THE EVENT. IT WAS NOT REPORTED WHETHER THE PT WAS HOSPITALIZED PRIOR TO DEATH. IT WAS NOT REPORTED WHETHER THE PT WAS CONNECTED TO THE HC AT THE TIME OF DEATH OR IF PD THERAPY WAS ONGOING UNTIL THE TIME OF DEATH. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411105 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Death DIANEAL PD4 2.5% AND 4.25% AMBUFLEX