BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 4111348 · Received September 23, 2014

    Report

    Report Number
    1416980-2014-32837
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 29, 2014
    Report Date
    August 29, 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). THE DEVICE WAS MANUFACTURED ON FEBRUARY 27, 2014 ¿ MARCH 4, 2014. EVALUATION SUMMARY: THE SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION IDENTIFIED A SOLID WHITE PARTICLE APPROXIMATELY 2.45MM IN LENGTH, FLOATING IN THE FLUID OF THE BLADDER. DURING A FOURIER TRANSFORM INFRARED SPECTROSCOPY SCAN IT WAS IDENTIFIED THAT THE PARTICULATE MATTER WAS AN ACRYLIC MATERIAL. THE CAUSE OF THE PARTICULATE IS UNKNOWN. A CAPA HAS BEEN OPENED TO ADDRESS THIS ISSUE. 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 BY BAXTER; EVALUATION IS CURRENTLY IN PROCESS BUT HAS NOT YET BEEN COMPLETED. UPON COMPLETION OF THE DEVICE EVALUATION, 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 RESERVOIR OF A LARGE VOLUME INTERMATE. THIS MALFUNCTION OCCURRED DURING FILLING. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589552 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 14B047

    Patients

    Seq Age Sex Outcome Treatment
    1