BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 3855190 · Received June 9, 2014

    Report

    Report Number
    1416980-2014-18306
    Event Type
    Malfunction
    Date Received
    June 9, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 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 FEBRUARY 14, 2014 ¿ FEBRUARY 18, 2014. EVALUATION SUMMARY: THE SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION IDENTIFIED WHITE PARTICLES BETWEEN 0.02-3.00 MM IN SIZE FLOATING IN THE BLADDER. FOURIER TRANSFORM INFRARED (FTIR) SPECTROSCOPY DETERMINED THAT THE PARTICLES WERE ACRYLIC MATERIAL. THE CAUSE OF THE PARTICULATE MATTER 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 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 IN THE BALLOON OF A SMALL VOLUME INTERMATE. THIS WAS NOTED DURING FILLING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335471 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 14B011

    Patients

    Seq Age Sex Outcome Treatment
    1