BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS® SYRINGE MODULE SET

    MDR report key: 5628813 · Received May 3, 2016

    Report

    Report Number
    9616066-2016-00640
    Event Type
    Malfunction
    Date Received
    May 3, 2016
    Date of Event
    March 26, 2016
    Report Date
    April 26, 2016
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K811885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: BAXTER 250ML IV BAG OF EXACTAMIX, REF H938737, LOT 1102114, EXP. 11/2018, THERAPY DATE (B)(6) 2016. 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

    ALTHOUGH REQUESTED, THE AFFECTED PRODUCT HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE AFFECTED PRODUCT BE RECEIVED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S REPORT OF A LEAK AT THE FILTER WAS CONFIRMED. INITIAL VISUAL INSPECTION SHOWED NO OBVIOUS DAMAGES OR ISSUES. FUNCTIONAL TESTING CONFIRMED LEAKING AT THE ENGAGEMENT BETWEEN THE DISTAL END OF THE FILTER AND THE TUBING. DIMENSIONAL ANALYSIS FOUND THE TUBING TO BE WITHIN SPECIFICATION. THE ROOT CAUSE OF THE LEAK AT THE FILTER WAS IDENTIFIED AS A MANUFACTURING ISSUE DUE TO INSUFFICIENT SOLVENT APPLIED AT THE ENGAGEMENT OF THE TUBING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN INFUSION OF TPN WAS NOTED TO BE LEAKING AT THE FILTER AFTER INFUSING FOR LESS THAN 24 HOURS. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283560 ALARIS® SYRINGE MODULE SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 10798696

    Patients

    Seq Age Sex Outcome Treatment
    1 21 DA