BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE IV ADMINISTRATION SET

    MDR report key: 2060644 · Received April 8, 2011

    Report

    Report Number
    9616066-2011-00116
    Event Type
    Malfunction
    Date Received
    April 8, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 18, 2011
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S REPORT DATE: 04/08/2011. (B)(4). AN INVESTIGATION COULD NOT BE PERFORMED. REPORTER INDICATED THAT THE DEVICE IS NOT AVAILABLE FOR EVAL. THE CAUSE OF REPORTED LEAK IS UNK.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT DURING A CHEMO INFUSION (PACLITAXEL), THE IV SET LEAKED. UNSURE OF LEAK LOCATION - ONE REPORT SAID IT LEAKED FROM THE FILTER AND ANOTHER SAID THAT IT LEAKED FROM THE MALE LUER LOCK CONNECTION. APPROX 1 ML OF CHEMO LEAKED ONTO THE LINEN AND 5 MLS LEAKED ONTO THE FLOOR. THE SET WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE IV ADMINISTRATION SET FPA CAREFUSION CORP. 10010454 10125970

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PUMP MODULE: S/N # UNK| ALARIS PC UNIT: S/N # UNK