BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 4810566 · Received June 2, 2015

    Report

    Report Number
    1416980-2015-23600
    Event Type
    Malfunction
    Date Received
    June 2, 2015
    Date of Event
    May 11, 2015
    Report Date
    May 11, 2015
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED WHITE PARTICULATE MATTER FLOATING INSIDE OF THE DEVICE. 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). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A WHITE FLOATING PARTICLE IN A SMALL VOLUME INTERMATE. THE PARTICULATE MATTER WAS IDENTIFIED AFTER THE DEVICE WAS COMPOUNDED WITH TOBRAMYCIN, DURING STORAGE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356103 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 15A021

    Patients

    Seq Age Sex Outcome Treatment
    1