BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 3872251 · Received June 13, 2014

    Report

    Report Number
    1416980-2014-18893
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 19, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT 14B047 WAS MANUFACTURED BETWEEN FEBRUARY 27, 2014 AND MARCH 4, 2014. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE AFFECTED DEVICE WAS RECEIVED FOR EVALUATION. THE VISUAL INSPECTION ON THE UNIT (VIA THE NAKED EYE) NOTED WHITE PARTICULATE BETWEEN 0.10 TO 5.00MM IN SIZE FLOATING IN THE FLUID OF THE RESERVOIR. THE PARTICLES WERE IDENTIFIED TO BE ACRYLIC MATERIAL VIA FTIR SPECTROPHOTOMETER SCANNING. NO CAUSE COULD BE DETERMINED AS TO THE ORIGIN OF THE PARTICULATE. A CAPA HAS BEEN OPENED TO ADDRESS THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LARGE VOLUME INTERMATE HAD PARTICULATE MATTER INSIDE THE RESERVOIR. THIS WAS NOTED DURING FILLING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349945 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 14B047

    Patients

    Seq Age Sex Outcome Treatment
    1