BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 3060001 · Received March 19, 2013

    Report

    Report Number
    9616066-2013-00184
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 8, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S REPORT DATE : 03/19/2013. (B)(4). PATIENT INFORMATION REQUESTED AND ALL AVAILABLE INFORMATION IS INCLUDED. NO PRODUCT WILL BE RETURNED PER CUSTOMER AS SET WAS NOT SAVED. THE CUSTOMER COMPLAINT OF LEAKING CONNECTION COULD NOT BE CONFIRMED DUE TO THE PRODUCT WAS NOT RETURNED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    PHARMACIST REPORTED CHEMO LEAKED BETWEEN CAREFUSION SET AND TEVADAPTOR SYRINGE ADAPTOR CLOSED SYSTEM DEVICE. CANCER PATIENT RECEIVING PACLITAXEL 173 MG, PACLITAXEL ADDED TO 250 ML BAG NS. INFUSION GIVEN OVER ONE HOUR. NEAR BEGINNING OF INFUSION, PATIENT WENT TO RESTROOM, NOTICED LEAKING FROM SET/SYRINGE CONNECTOR INTERFACE LOCATION, INFORMED RN OF CHEMO DRIPPING TO FLOOR. RN STOPPED THE LEAK, CLEANED UP THE SPILL , AND NO HARM TO PATIENT OR STAFF OCCURRED. NO OTHER ISSUES REPORTED WITH THE INFUSION. NO MEDICAL INTERVENTION WAS REQUIRED. CUSTOMER STATED THAT THE USER DID NOT PROVIDE ANY ADDITIONAL PATIENT/EVENT DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113105 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORPORATION 11130148 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK