BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 4121805 · Received September 26, 2014

    Report

    Report Number
    1416980-2014-33377
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Report Date
    September 2, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 NOVEMBER 30, 2010 TO DECEMBER 1, 2010. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RETURNED; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LARGE VOLUME INTERMATE HAD A MISSING ¿BLUE TIP¿ OR A MISSING ¿TOP TIP.¿ THERE WAS NO PATIENT INVOLVEMENT AS THIS WAS IDENTIFIED BEFORE PATIENT USE. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 6 OF 9.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601724 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 10N008

    Patients

    Seq Age Sex Outcome Treatment
    1