BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYRINGE MODULE SETS

    MDR report key: 7638389 · Received June 26, 2018

    Report

    Report Number
    9616066-2018-00882
    Event Type
    Malfunction
    Date Received
    June 26, 2018
    Report Date
    May 29, 2018
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K811885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONT'D FROM MEDICAL DEVICES: 8015;8100;8110;2426-0500;ICU MEDICAL, THERAPY DATE UNK. ALTHOUGH REQUESTED, THE AFFECTED PRODUCT HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICES BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A MULTI-MODULE INFUSION, THE MORPHINE SULFATE (0.01 ML/HR, VIA A 60 ML SYRINGE) INFUSION LEAKED. THE LEAK WAS OBSERVED BETWEEN THE MICROCLAVE ATTACHED TO THE MEDICATION SYRINGE AND THE SYRINGE PUMP TUBING. THE SETUP, STARTING AT THE SYRINGE MODULE INCLUDED: A 60 ML SYRINGE CONNECTED TO A MICROCLAVE, THEN THE SYRINGE PUMP TUBING , THEN A MICROCLAVE, THEN THE PATIENT¿S SMALL PICC (THOUGHT TO BE 1.0 OR 1.2 FR). ANOTHER MEDICATION WITH THE SAME NEEDLELESS CONNECTOR AND TUBING SET UP (PRECEDEX, 0.37 ML/HR IN A 30 ML SYRINGE) WAS ALSO ATTACHED TO THE PICC EXTENSION TUBING VIA ANOTHER PORT. AT THE TIME OF THE EVENT, THE INFANT WAS EXHIBITING WITHDRAWAL SYMPTOMS, AND THE LEAK WAS DISCOVERED DURING TROUBLESHOOTING OF THE TUBING. NO OTHER EFFECT TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480638 ALARIS SYRINGE MODULE SETS SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 10015612

    Patients

    Seq Age Sex Outcome Treatment
    1 49 DA