BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 4874960 · Received June 29, 2015

    Report

    Report Number
    1416980-2015-26989
    Event Type
    Malfunction
    Date Received
    June 29, 2015
    Date of Event
    June 11, 2015
    Report Date
    June 11, 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). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS LOT WAS MANUFACTURED FROM JANUARY 9, 2015 ¿ JANUARY 12, 2015. THE DEVICE WAS RECEIVED FOR EVALUATION. DURING VISUAL INSPECTION, PARTICULATE MATTER WAS OBSERVED WITHIN THE DEVICE. THE CAUSE OF THE CONDITION COULD NOT BE 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 CONTAINED WHITE, FLOATING PARTICULATE MATTER. THE DEVICE WAS FILLED WITH AN UNSPECIFIED AMOUNT OF CEFTAZAMINE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419137 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 15A008

    Patients

    Seq Age Sex Outcome Treatment
    1