BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 3792712 · Received May 6, 2014

    Report

    Report Number
    1416980-2014-14555
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 14, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS REPORTED TO BE AVAILABLE FOR EVALUATION, AND A REQUEST FOR ITS RETURN HAS BEEN MADE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT WAS MANUFACTURED BETWEEN JANUARY 27, 2014 ¿ JANUARY 29, 2014. EVALUATION INFORMATION: THE SAMPLE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION IDENTIFIED THAT THERE WAS A BLACK PARTICLE. THE PARTICLES WERE DETERMINED TO BE A DEPOSIT OF A SECONDARY AMIDE BASED ADHESIVE CONTAINING ADHERENT PAPER FIBERS AND ALUMINUM PARTICLES DURING A SPECTROSCOPY ANALYSIS. THE CAUSE OF THE PARTICLES IS UNKNOWN. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BLACK PARTICLES WERE FOUND INSIDE OF THE "RUBBER" OF A SMALL VOLUME INTERMATE. THIS WAS NOTICED BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270349 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 14A036

    Patients

    Seq Age Sex Outcome Treatment
    1