BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 4180336 · Received October 17, 2014

    Report

    Report Number
    1416980-2014-36205
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 23, 2014
    Report Date
    September 23, 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). EVALUATION SUMMARY: THE DEVICE WAS RECEIVED FOR EVALUATION. DURING VISUAL INSPECTION, A WHITE PARTICLE MEASURING APPROXIMATELY 1.49 MM IN LENGTH WAS OBSERVED FLOATING IN THE FLUID WITHIN THE RESERVOIR. THE PARTICLE WAS WITHIN THE FLUID PATH. FOURIER TRANSFORM INFRARED SPECTROSCOPY DETERMINED THE PARTICLE TO BE AN ACRYLIC MATERIAL. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE CAUSE OF THE PROBLEM IS UNKNOWN. 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). 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 THAT A LARGE VOLUME INTERMATE HAD PARTICULATE MATTER WITHIN ITS BLADDER. THIS WAS FOUND DURING FILLING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663290 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 14E009

    Patients

    Seq Age Sex Outcome Treatment
    1