BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 3812886 · Received April 25, 2014

    Report

    Report Number
    9616066-2014-00406
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    March 26, 2014
    Report Date
    April 7, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REPORT DATE: APRIL 25, 2014. INTERNAL FILE NO: (B)(4). THIS REPORT WAS FILED BY THE MANUFACTURER. THE AFFECTED PRODUCT HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD BE DEVICE BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE " USER DETECTED THE SECONDARY MEDICATION BEING INFUSED BACK INTO THE PRIMARY LINE INSTEAD OF INFUSING DOWN TO THE PUMP. THE LINES WERE HUNG PROPERLY. NO MALFUNCTION DETECTED WITH THE ALARIS PUMP. USER CHANGED THE PRIMARY CAREFUSION SET AND ATTACHED THE SECONDARY MEDICATION ON THE SAME PUMP, AND MEDICATION INFUSED PROPERLY." NO PATIENT HARM OR MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL PATIENT/EVENT INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251346 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORPORATION 2420-0500 14025141

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PC UNIT, SNS UNKNOWN| ALARIS PUMP MODULE, SNS UNKNOWN