BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS® SYRINGE MODULE SET

    MDR report key: 5628882 · Received May 3, 2016

    Report

    Report Number
    9616066-2016-00643
    Event Type
    Malfunction
    Date Received
    May 3, 2016
    Date of Event
    April 10, 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: 250ML EXACTAMIX INFUSION BAG REF H938737 (LOT 1100485 EXP 2018-10); BD 20 ML SYRINGE; BD 30ML SYRINGE; 10241342; QUAD-FUSE MICROCLAVE EXTENSION SET; (2) MICROCLAVE VALVES; THERAPY DATE (B)(6) 2016. THE CUSTOMER¿S REPORT THAT THE TUBING LEAKED WAS CONFIRMED. FUNCTIONAL TESTING FOUND THE SET LEAKING BETWEEN THE TUBING AND THE DISTAL END OF THE FILTER. INSUFFICIENT SOLVENT WAS OBSERVED AT THE ENGAGEMENT BETWEEN THE TUBING AND THE DISTAL END OF THE FILTER. DIMENSIONAL ANALYSIS CONFIRMED THE TUBING WAS WITHIN SPECIFICATION. THE ROOT CAUSE OF THE LEAK WAS INSUFFICIENT SOLVENT HAVING BEEN APPLIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN INFUSION OF TPN AND LIPIDS WAS NOTED TO BE LEAKING AT AN UNSPECIFIED LOCATION AFTER 14 HOURS OF INFUSION. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282256 ALARIS® SYRINGE MODULE SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 10798696

    Patients

    Seq Age Sex Outcome Treatment
    1 41 DA