BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 4131635 · Received October 1, 2014

    Report

    Report Number
    1416980-2014-33993
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 6, 2014
    Report Date
    September 6, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THIS IS A REPORT OF A PATIENT WHO DID NOT FOLLOW THERAPY STEPS DURING PERITONEAL DIALYSIS THERAPY. THE PATIENT CONNECTED TO THE PATIENT LINE BEFORE PRIMING WAS COMPLETE. TECHNICAL SERVICES ADVISED THE PATIENT TO END THERAPY AND START OVER WITH NEW SUPPLIES. THE PATIENT UNDERSTOOD AND WOULD CONTINUE THERAPY WITH ALL NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612100 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR HOMECHOICE