BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSO.R.

    MDR report key: 2771859 · Received October 4, 2012

    Report

    Report Number
    1416980-2012-01522
    Event Type
    Malfunction
    Date Received
    October 4, 2012
    Date of Event
    September 18, 2012
    Report Date
    September 18, 2012
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K883577
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE OF THE REPORTED PROBLEM WAS DEFINITIVELY IDENTIFIED A BROKEN PUSHER BLOCK ASSEMBLY. THE PUSHER BLOCK ASSEMBLY WAS REPLACED TO FIX THE PROBLEM.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. UPON COMPLETION OF BAXTER'S INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED AN INFUSO.R. PUMP WITH A CONDITION OF 'UP AND DOWN LEVER CONNECTING THE SYRINGE TO THE DEVICE IS BROKEN.' IT IS UNKNOWN WHEN THIS CONDITION OCCURRED. HOWEVER, IT IS KNOWN TO HAVE OCCURRED IN THE ANESTHESIA DEPARTMENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY ACCORDING TO THE HOSPITAL REPRESENTATIVE. NO PATIENT INVOLVEMENT IS UNKNOWN. THE CUSTOMER IS NOT WILLING TO BE CONTACTED. THEREFORE, NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSO.R. PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1