BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALARIS SYSTEM PUMP MODULE

    MDR report key: 1242535 · Received November 20, 2008

    Report

    Report Number
    2016493-2008-00171
    Event Type
    Other
    Date Received
    November 20, 2008
    Date of Event
    October 21, 2008
    Report Date
    October 21, 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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION IS INCLUDED.

    Description of Event or Problem · 1

    CARDINAL HEALTH SERVICE REPORTED DEVICE CAME IN FOR ROUTINE SERVICE AND VISUAL EXAM FOUND STICKY RESIDUE ON OCCLUDERS AND PUMP FINGERS. VERIFIED THAT THE RESIDUE IS NOT HINDERING MOVEMENT OF THE MECHANISM ASSEMBLY. AN INVESTIGATION FOR THIS FAILURE MODE HAS PREVIOUSLY BEEN DONE BY CARDINAL HEALTH. IT HAS BEEN DETERMINED THAT RESIDUE ON OCCLUDERS, FOUND TO BE FROM A LEAK PATH BETWEEN THE MEMBRANE FRAME AND BEZEL ASSEMBLY, HAS THE POTENTIAL TO MALFUNCTION IF THE OCCLUDERS BECOME STUCK, AND CAUSE RATE INACCURACIES. THIS ISSUE HAS BEEN ADDRESSED BY ISSUANCE OF CAPA TO EXPLORE DESIGN OPTIONS. CONTACTED CUSTOMER TO DETERMINE IF DEVICE WAS EVER REPORTED TO HAVE INFUSION INACCURACY. NO REPORTS OF ACCURACY RELATED EVENTS WITH THIS 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