BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 3983191 · Received June 27, 2014

    Report

    Report Number
    9616066-2014-00614
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    May 24, 2014
    Report Date
    June 6, 2014
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICES NOT RECEIVED, LOG REVIEW ONLY. THE CUSTOMER HAS REQUESTED AN EVENT LOG REVIEW TO SEE IF THE BACKFLOW WAS CAUSED BY THE PUMP. THE EVENT LOGS HAVE BEEN RECEIVED AND THE EVAL IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS ONCE THE EVAL HAS BEEN COMPLETED. THE TUBING WAS REQUESTED, BUT HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    A VANCOMYCIN SECONDARY INFUSION BAG WAS CONNECTED TO THE FLUSH LINE AND WITHIN 15 MINUTES, THE VANCOMYCIN SOLUTION BAG WAS ALMOST EMPTY. THE FLUSH BAG APPEARED TO HAVE MORE VOLUME THAN IT STARTED WITH. THERE IS A SUSPICION THAT PERHAPS VANCOMYCIN BACKED UP INTO THE FLUSH BAG. NO PT HARM OR MEDICAL INTERVENTION WAS REPORTED. NO FURTHER PT/EVENT INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377802 ALARIS PUMP MODULE ADMINISTRATION SET IV SET FPA CAREFUSION CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK SECONDARY SET, MFR/MODEL/LOT UNKNOWN| ALARIS PC UNIT, SN UNKNOWN| ALARIS PUMP MODULE, SN # (B)(4)