BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 4532540 · Received February 20, 2015

    Report

    Report Number
    1416980-2015-06558
    Event Type
    Malfunction
    Date Received
    February 20, 2015
    Date of Event
    January 26, 2015
    Report Date
    January 26, 2015
    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

    COMPLAINT NO: (B)(4). THE DEVICE WAS MANUFACTURED BETWEEN 11/11/2014 AND 11/13/2914. A DEVICE WAS RECEIVED FOR EVALUATION. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. A VISUAL INSPECTION WAS PERFORMED WITH PARTICLES NOTED IN THE FLUID OF THE RESERVOIR. A FOURIER TRANSFORM INFRARED SPECTROSCOPY WAS PERFORMED AND THE PARTICLES WERE IDENTIFIED AS ACRYLIC MATERIAL. A CAPA WAS REFERENCED FOR THIS EVENT. 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 HAD PARTICULATE MATTER INSIDE THE BALLOON. THE DEVICE WAS FILLED WITH AN ANTIBIOTIC SOLUTION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122858 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 14M015

    Patients

    Seq Age Sex Outcome Treatment
    1