BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS

    MDR report key: 19040225 · Received April 4, 2024

    Report

    Report Number
    19040225
    Event Type
    Malfunction
    Date Received
    April 4, 2024
    Date of Event
    February 12, 2024
    Report Date
    February 28, 2024
    Manufacturer
    BD SWITZERLAND SARL
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SITUATION: TOTAL PARENTERAL NUTRITION (TPN) IV TUBING FOUND TO HAVE PINPOINT HOLE AND LEAKING IVF. TPN WAS ATTACHED TO DOUBLE LUMEN PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE. BACKGROUND: PINHOLE FOUND IN A PORTION OF THE LINE THAT HANGS DOWN FROM THE RADIANT WARMER TO THE PUMP. ASSESSMENT: REGISTERED NURSE (RN) FOUND TPN LINE TO BE STICKY AND APPEARED TO HAVE CONDENSATION DROPLETS ON THE OUTSIDE OF THE LINE DURING AN AIR VIGILANCE CHECK. THE LINE WAS CLEANSED WITH PREVANTICS AND FOUND PINHOLE LEAK IN LINE. DROPLETS OF IVF WERE FOUND ALONG THE LINE AND ON THE FLOOR. INFUSION WAS STOPPED AND TEAM NOTIFIED. NEW TPN WAS ORDERED AND HUNG WITH NEW IV TUBING. RECOMMENDATION: INSPECT TUBING FOR DEFECT. RN FOUND FLUIDS TO BE LEAKING, LINE HAS A SLIGHT TEAR IN IT. POSSIBLY OCCURRING DUE TO TUBING BEING PINCHED RADIANT WARMER SIDES. LOT #: 1023125013 (LOT NUMBER MAY NOT BE ACCURATE AS ORIGINAL PRODUCT PACKAGING WAS DISCARDED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2340135 ALARIS SET, ADMINISTRATION, INTRAVASCULAR FPA BD SWITZERLAND SARL 10942011 1023125013

    Patients

    Seq Age Sex Outcome Treatment
    1 10 DA Female