BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 3252593 · Received July 15, 2013

    Report

    Report Number
    9616066-2013-00537
    Event Type
    Malfunction
    Date Received
    July 15, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 26, 2013
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    K951922
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER STATED THAT THE PRODUCT WILL NOT BE RETURNED DUE TO A FACILITY POLICY WHICH PREVENTS THEM FROM RETURNING USED PRODUCT TO VENDORS FOR INVESTIGATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A CHEMOTHERAPY SPILL. PHOTO INCLUDED IN THE E-MAIL SHOWS A DROP LEAKING AT THE BOTTOM OF THE BURETTE. NO PT HARM REPORTED AND NO MEDICAL INTERVENTION WAS REQUIRED. ALTHOUGH REQUESTED, NO ADDITIONAL EVENT OR PT INFO PROVIDED BY THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327467 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORP 2447-0600 12055537

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PUMP MODULE: SN UNK| ALARIS PC UNIT: SN UNK