BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 4915804 · Received July 15, 2015

    Report

    Report Number
    1416980-2015-28925
    Event Type
    Malfunction
    Date Received
    July 15, 2015
    Date of Event
    July 2, 2015
    Report Date
    July 2, 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 RECEIVED AND IS CURRENTLY AWAITING EVALUATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE DEVICE WAS MANUFACTURED FEBRUARY 23, 2015 ¿ FEBRUARY 26, 2015. THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION NOTED WHITE FLOATING PARTICLES INSIDE THE DEVICE. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE PARTICULATE MATTER 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 HAD WHITE FLOATING PARTICULATE MATTER. THE DEVICE WAS COMPOUNDED WITH CLINDAMYCIN. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459849 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 15B006

    Patients

    Seq Age Sex Outcome Treatment
    1