BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 2942611 · Received February 4, 2013

    Report

    Report Number
    1416980-2013-02906
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    January 31, 2013
    Report Date
    January 31, 2013
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RECEIVED FOR EVALUATION. DURING VISUAL INSPECTION THE CUSTOMER REPORTED CONDITION WAS CONFIRMED TO BE BROKEN TUBING AT THE DISTAL LUER PORT. THE ROOT CAUSE COULD NOT BE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. UPON COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW-UP WILL BE SUBMITTED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER PRODUCT SURVEILLANCE TO REPORT AN ISSUE WITH ONE CE INTERMATE SV 200 ELASTOMERIC. ACCORDING TO THE REPORT, THE CUSTOMER NOTED THAT THE TUBING WAS CUT AND HAD NO LUER AT THE PATIENT END OF THE TUBING. THERE WAS NO PATIENT INVOLVEMENT AND, THEREFORE, NO ADVERSE EVENT OR PATIENT INJURY IN ASSOCIATION WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46702 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 12M079

    Patients

    Seq Age Sex Outcome Treatment
    1