BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALARIS SYSTEM PUMP MODULE

    MDR report key: 1121324 · Received August 13, 2008

    Report

    Report Number
    2016493-2008-00105
    Event Type
    Other
    Date Received
    August 13, 2008
    Report Date
    July 22, 2008
    Manufacturer
    CARDINAL HEALTH ALARIS PRODUCTS
    Product Code
    FRN
    PMA / PMN Number
    K012383
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CARDINAL HEALTH SERVICE DEPARTMENT REPORTED DEVICE CAME IN FOR SERVICE AND VISUAL EXAM FOUND DRY RESIDUE ON THE OCCLUDERS. VERIFIED THAT THE RESIDUE WAS NOT HINDERING THE MOVEMENT OF THE MECHANISM ASSEMBLY. AN INVESTIGATION FOR THIS FAILURE MODE HAD BEEN DONE AND CARINAL HEALTH HAS DETERMINED A REPORT OF RESIDUE ON OCCLUDERS IS A POTENTIAL MALFUNCTION. IF OCCLUDERS WERE TO STICK, RATE INACCURACIES COULD OCCUR. CUSTOMER NOTIFIED OF RESIDUE ON OCCLUDERS. REPORTED NO PATIENT EVENTS OF RATE INACCURACIES FOR THE HISTORY OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS SYSTEM PUMP MODULE FRN INFUSION PUMP FRN CARDINAL HEALTH ALARIS PRODUCTS 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA