BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 3645895 · Received February 25, 2014

    Report

    Report Number
    1416980-2014-06722
    Event Type
    Injury
    Date Received
    February 25, 2014
    Date of Event
    January 5, 2014
    Report Date
    January 7, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PERITONEAL DIALYSIS (PD) PATIENT (PT) WHO PERFORMED PD THERAPY WITH A HOMECHOICE (HC) DEVICE EXPERIENCED SHORTNESS OF BREATH AND WAS HOSPITALIZED FOR THE EVENT ON THE SAME DAY. IT WAS REPORTED THAT THE SHORTNESS OF BREATH WAS DUE TO FLUID OVERLOAD (FURTHER DETAILS NOT PROVIDED). PD THERAPY WAS ONGOING FROM THE TIME THE PT WAS ADMITTED TO THE HOSPITAL FOR 2-3 DAYS UNTIL THE PATIENT¿S HEART STOPPED (DATE UNSPECIFIED). IT IS UNKNOWN IF THE PT WAS CONNECTED TO THE HC DEVICE AT THE TIME THE PATIENT¿S HEART STOPPED. TREATMENT WAS NOT REPORTED. SUBSEQUENTLY THE PT WAS SWITCHED TO HEMODIALYSIS FOR APPROXIMATELY 2 WEEKS, AFTER WHICH PD THERAPY WAS RESTARTED USING THE HOSPITAL¿S HC CYCLER. AT THE TIME OF THIS REPORT, THE PT WAS NOT RECOVERED FROM THE EVENT AND PD THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116928 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 18 MO Hospitalization DIANEAL PD2, 1.5% AMBUFLEX| DIANEAL 2.5%