BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 3133914 · Received May 1, 2013

    Report

    Report Number
    9616066-2013-00295
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 5, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    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). THE SET AND ASSOCIATED PUMP MODULE HAVE BEEN REC'D AND THE EVALUATION IS PENDING. A FOLLOW-UP REPORT WITH FAILURE INVESTIGATION RESULTS WILL BE SUBMITTED ONCE THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED CHEMO LEAKED FROM THE PUMP SEGMENT WHEN THE INFUSION WAS STARTED. THE IV SET WAS LOADED INTO THE PUMP MODULE, THE DOOR WAS CLOSED AND AS SOON AS THE PUMP WAS TURNED ON, CHEMO LEAKED ONTO THE FLOOR. UPON INSPECTION, THE CUSTOMER FOUND A SMALL CUT IN THE SILICONE TUBING BELOW THE UPPER FITMENT AND DAMGE ON THE PUMP MODULE NEAR THE UPPER FITMENT. BOTH THE IV SET AN PUMP MODULE WERE SEQUESTERED AND ARE AVAILABLE FOR EVALUATION. NO PT OR STAFF HARM AND NO MEDICAL INTERVENTION REQUIRED. NO FURTHER PT OR EVENT DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190971 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORPORATION 2426-0500 13026174

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PUMP MODULE: SN, (B)(4)| ALARIS PC UNIT: SN, UNK