BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 4240763 · Received November 10, 2014

    Report

    Report Number
    1416980-2014-39704
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 13, 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). THIS LOT WAS MANUFACTURED BETWEEN JUNE 5, 2014 AND JUNE 6, 2014. THE DEVICE WAS RETURNED AND AN EVALUATION WAS PERFORMED TO INVESTIGATE THE REPORTED EVENT. A VISUAL INSPECTION REVEALED A SOLID WHITE PARTICLE APPROXIMATELY 1.37 MM IN LENGTH FLOATING IN THE FLUID OF THE BLADDER. THE PARTICLE WAS IDENTIFIED TO BE AN ACRYLIC MATERIAL VIA FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) SPECTROPHOTOMETER SCANNING. THE ORIGIN OF THE PARTICULATE MATTER COULD NOT BE DETERMINED. THIS ISSUE IS CURRENTLY BEING ADDRESSED THROUGH A CAPA. 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.

    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 WAS OBSERVED TO HAVE PARTICULATE MATTER INSIDE THE BALLOON DURING FILLING OF AN UNSPECIFIED SOLUTION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723928 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 14F003

    Patients

    Seq Age Sex Outcome Treatment
    1