BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE.

    MDR report key: 3132241 · Received May 29, 2013

    Report

    Report Number
    1416980-2013-13541
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 6, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT NUMBER AND SAMPLE AVAILABILITY ARE UNKNOWN AT THIS TIME. BAXTER IS ATTEMPTING TO OBTAIN ADDITIONAL INFORMATION. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOME PATIENT (HP) HAD A TRANSFER SET THAT WAS LEAKING DURING DRAIN 4 OF 6, PATIENT WAS CONNECTED. THE PATIENT DISCONNECTED AND USED A CLAMP TO STOP THE LEAK. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235979 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE. KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1