BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 4211520 · Received October 29, 2014

    Report

    Report Number
    1416980-2014-37919
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    October 3, 2014
    Report Date
    October 4, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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 DID NOT UNCLAMP THE PATIENT LINE AND CONNECTED TO AN IMPROPERLY PRIMED PATIENT LINE. 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. THE GUIDE ALSO INFORMS THE USER TO OPEN THE CLAMPS ON THE LINES CONNECTED TO THE SOLUTION BAGS AND THE PATIENT LINE TO ENSURE PROPER PRIMING. THE USERS ARE NOT INSTRUCTED TO CLOSE THE PATIENT LINE CLAMP ANYTIME DURING THE THERAPY EXCEPT FOR AN EMERGENCY DISCONNECT PROCEDURE. A 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 PATIENT MADE A MISTAKE WHILE PRIMING THE LINES OF THE SET BY NOT OPENING THE PATIENT LINE CLAMP. AS A RESULT, THE PATIENT LINE WAS NOT PROPERLY PRIMED WHEN THE PATIENT CONNECTED. THE TECHNICAL SERVICE REPRESENTATIVE REVIEWED THE PROPER SETUP PROCEDURES WITH THE PATIENT AND ADVISED TO 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
    693334 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR HOMECHOICE