BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 4896640 · Received July 7, 2015

    Report

    Report Number
    1416980-2015-28023
    Event Type
    Malfunction
    Date Received
    July 7, 2015
    Date of Event
    June 17, 2015
    Report Date
    June 17, 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 HAS BEEN RECEIVED AND THE EVALUATION IS IN PROGRESS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED A BLACK PARTICLE APPROXIMATELY 0.02 SQUARE MM IN SIZE, EMBEDDED IN THE MATERIAL OF THE STRESSMEMBER COMPONENT. THE PARTICLE WAS NOT IN THE FLUID PATH, IT WAS MOLDED WITHIN THE MATERIAL OF THE STRESSMEMBER. 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 THERE WAS A BLACK MARK ON THE FILTER OF A LARGE VOLUME INTERMATE. THE BLACK MARK WAS IDENTIFIED AFTER THE DEVICE WAS COMPOUNDED WITH CIPROFLOXACIN, DURING THE STORAGE OF THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438784 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 14K002

    Patients

    Seq Age Sex Outcome Treatment
    1