BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 1813222 · Received August 19, 2010

    Report

    Report Number
    9616066-2010-00222
    Event Type
    Malfunction
    Date Received
    August 19, 2010
    Date of Event
    April 6, 2010
    Report Date
    May 21, 2010
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT WAS REQUESTED MULTIPLE TIMES TO BE RETURNED FOR EVAL. THE SET WAS NOT RETURNED AND THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, NO INVESTIGATION OR LOT HISTORY RECORD REVIEW COULD BE PERFORMED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TUBING DISCONNECTED WHERE IT ENTERS BURETROL. NO PT HARM REPORTED. ALTHOUGH REQUESTED, NO ADD'L INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORP. 2141-0600 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK