BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 4844108 · Received June 15, 2015

    Report

    Report Number
    1416980-2015-25217
    Event Type
    Malfunction
    Date Received
    June 15, 2015
    Date of Event
    May 25, 2015
    Report Date
    May 25, 2015
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS MANUFACTURED JULY 14, 2013 ¿ JULY 15, 2013. THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED A WHITE PARTICLE APPROXIMATELY 1.89 MM IN LENGTH, FLOATING IN THE BLADDER. FOURIER TRANSFORM INFRARED SPECTROSCOPY IDENTIFIED THE PARTICLE TO BE ACRYLIC. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS IN PROGRESS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LARGE VOLUME INTERMATE HAD WHITE PARTICULATE MATTER. THE DEVICE WAS FILLED WITH AN UNSPECIFIED AMOUNT OF VANCOMYCIN. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387512 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 13G045

    Patients

    Seq Age Sex Outcome Treatment
    1