BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYRINGE MODULE SETS

    MDR report key: 7220035 · Received January 25, 2018

    Report

    Report Number
    9616066-2018-00102
    Event Type
    Malfunction
    Date Received
    January 25, 2018
    Date of Event
    January 3, 2018
    Report Date
    January 10, 2018
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K811885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE INVESTIGATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: REMOVE ME1250. THE CUSTOMER¿S REPORT OF LEAKING BETWEEN THE NON-BD CONNECTOR AND THE TUBING WAS CONFIRMED. NO CRACKS, DAMAGE, OR OTHER ANOMALIES WERE OBSERVED ON THE SETS AND CONNECTOR DURING VISUAL INSPECTION. FUNCTIONAL AND PRESSURE TESTING CONFIRMED A LEAK AT THE CONNECTION BETWEEN THE FEMALE LUER OF THE SYRINGE PSD MICROBORE SET AND THE MALE LUER OF THE NON-BD CONNECTOR. DIMENSIONAL ANALYSIS DETERMINED THE SET TO BE WITHIN ISO SPECIFICATION. UPON DISCONNECTION OF THE SETS, IT WAS NOTED THAT THE CONNECTION IN THE SAME LOCATION WAS NOT FULLY TIGHTENED. THE ROOT CAUSE OF THE LEAK WAS DUE TO A NOT FULLY TIGHTENED CONNECTION BETWEEN THE FEMALE LUER OF THE SYRINGE SET AND THE MALE LUER OF THE NON-BD CONNECTOR.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN INFUSION OF KETAMINE WAS NOTED TO BE LEAKING BETWEEN THE NON-BD CONNECTOR AND THE TUBING. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62401 ALARIS SYRINGE MODULE SETS SET,ADMINISTRATION,INTRAVASCULAR FPA CAREFUSION 10014914

    Patients

    Seq Age Sex Outcome Treatment
    1