BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 3823707 · Received May 21, 2014

    Report

    Report Number
    1416980-2014-16317
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Report Date
    April 28, 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 SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF BAXTER'S INVESTIGATION, IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS MANUFACTURED FEBRUARY 14, 2014 ¿ FEBRUARY 18, 2014. EVALUATION SUMMARY: THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED PARTICLES BETWEEN 0.09 AND 0.3 MM IN SIZE FLOATING INSIDE THE SOLUTION OF THE BLADDER. THE PARTICLES WERE IN THE FLUID PATH. THE PARTICLES WERE IDENTIFIED TO BE ACRYLIC VIA FTIR SPECTROPHOTOMETER SCANNING. THE CAUSE OF THE CONDITION WAS NOT DETERMINED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SMALL VOLUME INTERMATE WAS OBSERVED TO HAVE PARTICLES INSIDE THE BALLOON. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE. THIS MEDICAL DEVICE REPORT IS REPORT 2 OF 7.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302235 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 14B011

    Patients

    Seq Age Sex Outcome Treatment
    1