BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTENSION SET

    MDR report key: 3913811 · Received July 3, 2014

    Report

    Report Number
    1416980-2014-21510
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K925403
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).AN EVENT INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE EXTENSION SET WAS IDENTIFIED. AS THE EXTENSION SET WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT OBSERVED A LEAK FROM THEIR PATIENT LINE EXTENSION SET DURING FILL ONE OF PERITONEAL DIALYSIS THERAPY. THE PATIENT WAS CONNECTED TO THE HOMECHOICE AT THE TIME OF THE OBSERVED LEAK. THE PATIENT WAS ADVISED TO START THERAPY OVER USING ALL NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION INDICATED WITH THE REPORTED CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390602 EXTENSION SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR HOMECHOICE