BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 2922915 · Received January 18, 2013

    Report

    Report Number
    1416980-2013-01425
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    December 25, 2012
    Report Date
    December 27, 2012
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CUSTOMER, THIS DEVICE IS NOT AVAILABLE FOR EVALUATION. THEREFORE, THE REPORTED CONDITION COULD NOT BE CONFIRMED, AND THE ROOT CAUSE COULD NOT BE DETERMINED. SHOULD THE DEVICE AND/OR ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS PRODUCT IS NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510(K) NUMBER.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A REPORT OF AN INFUSOR THAT LEAKED BETWEEN THE BLADDER AND THE HOUSING DURING PATIENT THERAPY. THE CONCOMITANT MEDICAL PRODUCTS ARE CURRENTLY UNKNOWN. THIS CONDITION HAS THE POTENTIAL TO INTERRUPT THERAPY OR BREACH THE STERILE FLUID PATHWAY. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28203 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE

    Patients

    Seq Age Sex Outcome Treatment
    1