BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 5080816 · Received September 16, 2015

    Report

    Report Number
    1416980-2015-36178
    Event Type
    Malfunction
    Date Received
    September 16, 2015
    Date of Event
    September 3, 2015
    Report Date
    October 7, 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 AT THE COMPOUNDING FACILITY NOTED PARTICULATE MATTER IN THE RESERVOIR. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE PARTICULATE COULD NOT BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. A CAPA HAS BEEN TO ADDRESS THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (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 WERE WHITE FLOATING PARTICLES IN A SMALL VOLUME INTERMATE. THIS OCCURRED BEFORE USE AFTER THE DEVICE WAS COMPOUNDED WITH COLISTIMETHATE. NO PATIENT INVOLVED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612774 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 15C024

    Patients

    Seq Age Sex Outcome Treatment
    1