BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYRINGE MODULE SETS

    MDR report key: 7444342 · Received April 19, 2018

    Report

    Report Number
    9616066-2018-00509
    Event Type
    Malfunction
    Date Received
    April 19, 2018
    Date of Event
    February 6, 2018
    Report Date
    April 11, 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 · 0

    THE CUSTOMER¿S REPORT OF A LEAK OF LIPIDS AT THE CONNECTION SITE OF THE TUBING AND THE NON-BD CONNECTOR (DETERMINED TO BE A MICROCLAVE CONNECTOR) WAS CONFIRMED. THE SYRINGE PSD MICROBORE SET WAS DISCONNECTED FROM THE MALE LUER SIDE OF THE MICROCLAVE CONNECTOR AND WAS INSPECTED UNDER MAGNIFICATION AND NO DAMAGE WAS OBSERVED ON EITHER COMPONENT. FUNCTIONAL SYRINGE INFUSION TESTING CONFIRMED A SLOW LEAK ON THE THREADS OF THE MICROCLAVE CONNECTOR AT THE CONNECTION TO THE FEMALE LUER OF THE SYRINGE MICROBORE SET. PRESSURE TESTING RESULTED IN NO LEAKING. THE NON-BD CONNECTOR WAS REPLACED WITH A BD MAXZERO CONNECTOR AND THE TESTING WAS REPEATED, NO LEAKS WERE IDENTIFIED. DIMENSIONAL ANALYSIS WAS PERFORMED AND THE SET WAS WITHIN SPECIFICATION. THE ROOT CAUSE OF THE LEAK HAS BEEN IDENTIFIED DURING PREVIOUS CAE CT TESTING TO BE A POOR FITMENT OR SLIGHT LACK OF COMPATIBILITY BETWEEN THE SYRINGE PSD MICROBORE SET FEMALE LUER AND THE NON-BD MICROCLAVE CONNECTOR.

    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK OF LIPIDS AT THE CONNECTION SITE OF THE TUBING AND THE NON BD CONNECTOR. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288275 ALARIS SYRINGE MODULE SETS SYRINGE, PISTON FPA CAREFUSION 10014914

    Patients

    Seq Age Sex Outcome Treatment
    1 60ML BD SYRINGE,NON-BD EXT SET| 8110,8015,MICROCLAVE CONNECTOR, TD: (B)(6) 2018