BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS® SYRINGE MODULE SET

    MDR report key: 5628815 · Received May 3, 2016

    Report

    Report Number
    9616066-2016-00642
    Event Type
    Malfunction
    Date Received
    May 3, 2016
    Date of Event
    April 19, 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

    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

    CONCOMITANT PRODUCTS: BAXTER, 250ML IV BAG OF EXACTA MIX, LOT: 1100487, EXP: NOVEMBER 2018; THERAPY DATE (B)(6) 2016. THE CUSTOMER¿S REPORT THAT A SET LEAKED AT THE FILTER WAS CONFIRMED. NO ANOMALIES WERE OBSERVED DURING VISUAL INSPECTION. FUNCTIONAL AND PRESSURE TESTING WAS PERFORMED; THE SET LEAKED FROM THE MICROBORE TUBING TO THE OUTLET PORT OF THE MICRON FILTER. VISUAL INSPECTION UNDER MAGNIFICATION NOTED THAT BOTH SIDES OF THE MICROBORE TUBING HAD INSUFFICIENT SOLVENT APPLIED AT THE ENGAGEMENT DURING MANUFACTURING PROCESS. DIMENSIONAL ANALYSIS DETERMINED THAT THE TUBING WAS WITHIN SPECIFICATION. THE ROOT CAUSE OF THE LEAK WAS A MANUFACTURING ISSUE DUE TO INSUFFICIENT SOLVENT BEING APPLIED AT THE JUNCTION OF THE MICROBORE TUBING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN INFUSION 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
    283871 ALARIS® SYRINGE MODULE SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 10798696

    Patients

    Seq Age Sex Outcome Treatment
    1