BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 3060664 · Received March 27, 2013

    Report

    Report Number
    9616066-2013-00196
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 12, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE INVOLVED IN THIS EVENT WILL NOT BE RETURNED AS IT WAS NOT AVAILABLE. NO FAILURE INVESTIGATION COULD BE PERFORMED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE NURSE PRIMED THE LINE AND LOADED THE SET CORRECTLY (UPPER BLUE FITMENT FIRST) FOR AN INFUSION OF CHEMOTHERAPY (AMSACRINE). PT RANG BUZZER AS INFUSION WAS COMPLETE. ON ENTERING ROOM "THE NURSE NOTICED 5-10 MLS OF YELLOW FLUID ON THE FLOOR, PAUSED THE PUMP AND THEN NOTICED THAT YELLOW FLUID WAS RUNNING DOWN THE SILICONE TUBING, ALONG THE LINE WAS EVENTUALLY DRIPPING ONTO THE FLOOR. THE NURSE CANNOT REMEMBER THE EXACT POINT OF LEAKING, WHETHER BELOW/ABOVE BLUE FITMENT." FROM THE REPORTED INFO, THERE ARE NO INDICATIONS OF SERIOUS INJURY TO THE PT OR USER AS A RESULT OF THIS INCIDENT. NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126639 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORPORATION 2420-0500 UNK

    Patients

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