BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 3913815 · Received July 3, 2014

    Report

    Report Number
    1416980-2014-21513
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 9, 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) ADDITIONAL INFORMATION: MANUFACTURE DATE: MARCH 4, 2014 ¿ MARCH 6, 2014. EVALUATION: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS RECEIVED FOR EVALUATION. DURING VISUAL INSPECTION WHITE PARTICLES RANGING IN SIZE FROM 0.2 ¿ 0.6 MM WERE OBSERVED FLOATING IN THE FLUID WITHIN THE BLADDER. FOURIER TRANSFORM INFRARED SPECTROSCOPY DETERMINED THE PARTICLES TO BE MADE OF ACRYLIC MATERIAL. THE REPORTED PROBLEM WAS VERIFIED. THE CAUSE OF THE PROBLEM IS UNKNOWN. A CAPA HAS BEEN OPENED FOR THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP MDR 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 THERE WAS PARTICULATE MATTER INSIDE THE BALLOON OF A SMALL VOLUME INTERMATE. THIS WAS OBSERVED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 4 OF 5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389787 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 14C014

    Patients

    Seq Age Sex Outcome Treatment
    1