BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET, EXTENSION BLOODLINE FOR CRRT 36 IN CUSTOM

    MDR report key: 2633354 · Received June 11, 2012

    Report

    Report Number
    2633354
    Event Type
    Malfunction
    Date Received
    June 11, 2012
    Date of Event
    May 7, 2012
    Report Date
    June 11, 2012
    Manufacturer
    MOLDED PRODUCTS, INC.
    Product Code
    FID
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    LEAKING OCCURRED IN THE NEW CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) TUBING. THE LEAKING OCCURRED AT THE CONNECTION OF THE CALCIUM TO THE VENOUS ACCESS LINE. IT IS LEAKING AT A PERMANENT CONNECTION, NOT THE LUER LOCK. THE TUBING WAS SAVED. THE BLOOD WAS RETURNED AND NEW FILTER WAS SET UP. THE TUBING BEGAN LEAKING AFTER THE PATIENT WAS REPOSITIONED IN BED. THE PRACTITIONER MIGHT HAVE BEEN ABLE TO ONLY CHANGE OUT THE EXTENSION TUBING RATHER THAN THE WHOLE SET, BUT DECIDED TO CHANGE OUT THE ENTIRE SET. THE SET WAS THREE DAYS OLD AND THE TMP(TRANSMEMBRANE PRESSURE) WAS RISING.WE ARE AWAITING A RESPONSE FROM THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SET, EXTENSION BLOODLINE FOR CRRT 36 IN CUSTOM DIALYSIS EQUIPMENT (DESCRIBE BELOW) FID MOLDED PRODUCTS, INC. UM-872-36 POTENTIALLY LOT # 80106.

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR