BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 4110154 · Received September 23, 2014

    Report

    Report Number
    1416980-2014-32781
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 29, 2014
    Report Date
    August 29, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER WAS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS CONNECTED FOR THERAPY DURING THE PRIME. THE HOMECHOICE AND HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE, WHICH IS SHIPPED WITH EVERY HOMECHOICE DEVICE PROVIDES STEP-BY-STEP INSTRUCTIONS FOR PROPERLY PRIMING THE DISPOSABLE SET AND SAYS TO VERIFY THAT THE PATIENT LINE IS PROPERLY PRIMED. IT WARNS THE USER NOT TO CONNECT TO THE PATIENT LINE UNLESS THE FLUID LEVEL IS AT OR NEAR THE CONNECTOR AT THE END OF THE DISPOSABLE SET PATIENT LINE. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOME PATIENT (HP) FAILED TO FOLLOW THERAPY STEPS DURING PERITONEAL DIALYSIS (PD) THERAPY ON THE HOMECHOICE (HC) DEVICE. THE HP WAS NOT CONNECTED AT THE TIME OF THE CALL. THE CARE GIVER (CG) INFORMED THE TECHNICAL SERVICE REPRESENTATIVE (TSR) THAT THE HP WAS CONNECTED TO THE PATIENT LINE WHICH WAS NOT FULLY PRIMED. IT WAS NOTED THAT THE INCOMPLETE PRIME WAS DUE TO CLOSED PATIENT LINE CLAMP. THE TSR ADVISED THE CG THAT THE HP SHOULD START OVER WITH NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590298 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR HOMECHOICE