BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 3973274 · Received August 1, 2014

    Report

    Report Number
    1416980-2014-25051
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 6, 2014
    Report Date
    July 7, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K943664
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTERMATE ELASTOMERIC DEVICE STOPPED INFUSING. ACCORDING TO THE REPORTER, THE INTERMATE STOPPED INFUSING AFTER HALF OF THE SOLUTION HAD BEEN INFUSED. THE INTERMATE WAS FILLED WITH AN ANTIBIOTIC DILUTED IN 0.9% SODIUM CHLORIDE SOLUTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451242 INTERMATE PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 13K004

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR 0.9% NACL| MERONEM