BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 1811232 · Received August 11, 2010

    Report

    Report Number
    9616066-2010-00214
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Date of Event
    July 16, 2010
    Report Date
    July 26, 2010
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER INDICATED PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. THE LOT NUMBER WAS IDENTIFIED. THE MANUFACTURING DATABASE WAS REVIEWED; NO QUALITY ISSUES WERE NOTED DURING PRODUCTION BUILD FOR THE INVOLVED LOT NUMBER AND FAILURE MODE REPORTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN UNSPECIFIED SECONDARY MEDICATION WAS FLOWING FREELY INTO THE PRIMARY LINE. NO PT HARM REPORTED AND NO ADDITIONAL EVENT INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORPORATION 2420-0007 10055111

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK