BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 3914454 · Received July 3, 2014

    Report

    Report Number
    1416980-2014-21607
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    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). (B)(6). THE DEVICE WAS MANUFACTURED JANUARY 14, 2014 TO JANUARY 15, 2014. EVALUATION SUMMARY: THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE HOUSING WAS MALFORMED. THE CAUSE OF THE CONDITION WAS NOT 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 THE HOUSING OF A LARGE VOLUME INTERMATE WAS MALFORMED, AND THAT THE PANEL WALLS APPEARED TO BE ¿COLLAPSED.¿ THIS WAS NOTED AFTER FILLING THE DEVICE WITH ANTIBIOTIC. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389989 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 14A034

    Patients

    Seq Age Sex Outcome Treatment
    1