BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 1972697 · Received January 20, 2011

    Report

    Report Number
    9616066-2011-00015
    Event Type
    Malfunction
    Date Received
    January 20, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 22, 2010
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REPORT DATE: 01/20/2011. (B)(4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. SINCE THE PRODUCT WAS DISCARDED WE WERE UNABLE TO PERFORM AN INVESTIGATION, THE ROOT CAUSE OF CUSTOMER'S EXPERIENCE IS UNK.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TAXOL LEAKING FROM A PRIMARY ADMINISTRATION SET, MODEL AND LOT NUMBER UNK. ALTHOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS SYSTEM PC UNIT| ALARIS SYSTEM PUMP MODULE| SERIAL NUMBER UNK| SERIAL NUMBER UNK