BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 4250501 · Received November 14, 2014

    Report

    Report Number
    1416980-2014-40349
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Report Date
    October 20, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS LOT WAS MANUFACTURED FROM MAY 30, 2014 THROUGH JUNE 4, 2014. EVALUATION SUMMARY: THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION (VIA THE NAKED EYE) ON THE UNIT REVEALED THE PRESENCE OF A BLACK IRREGULARLY SHAPED PARTICLE LOCATED AT A CORNER OF THE WHITE MESH FILTER. THE DEVICE WAS APPROXIMATELY 0.02MM IN SIZE. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE PARTICLE COULD NOT BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THIS ISSUE IS CURRENTLY BEING ADDRESSED THROUGH A CAPA. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS IN PROGRESS. UPON COMPLETION OF THE INVESTIGATION, OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED A SMALL VOLUME INTERMATE WAS OBSERVED TO HAVE A BLACK PARTICLE DURING FILLING WITH FOSFOMYCIN AND 5% GLUCOSE. THE LOCATION OF THE PARTICLE WAS DESCRIBED AS BEING "SOMEWHERE AT THE INNER MIDDLE"; HOWEVER THE EXACT LOCATION WAS NOT SPECIFIED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737256 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 14E064

    Patients

    Seq Age Sex Outcome Treatment
    1 FOSFOMYCIN AND GLUCOSE 5%