BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 3223402 · Received July 12, 2013

    Report

    Report Number
    1416980-2013-18173
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 18, 2013
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ONE UNFILLED SAMPLE WAS RECEIVED FOR EVALUATION. NO DEFECTS WERE OBSERVED DURING VISUAL INSPECTION. THE SAMPLE WAS SUBSEQUENTLY FILLED WITH WATER TO ITS NOMINAL VOLUME FOR A FUNCTIONAL TEST. AFTER FILL, EVIDENCE OF FLOW WAS VISUALLY OBSERVED AT THE DISTAL LUER. FLOW CONTINUED WITHOUT STOPPING. NO EVIDENCE OF FLOW PROBLEM WAS OBSERVED DURING THE FUNCTIONAL TEST. THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE SAMPLE WAS WORKING WITHIN SPECIFICATION. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED AND REVEALED THAT ALL OF THE ACCEPTANCE CRITERIA WERE MET TO RELEASE THE LOT. THERE WERE NO NON-CONFORMANCES, FAILURES, REWORK, OR DEVIATIONS RELATED TO THE LOT. THERE WERE NO CHANGES TO SPECIFICATIONS, TEST METHODS, PROCESS, EQUIPMENT, OR RAW MATERIALS THAT COULD BE ASSOCIATED WITH THE REPORTED CONDITION. A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTERMATE HAD NO FLOW DURING SET UP. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THE REPORTED CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324328 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 12M049

    Patients

    Seq Age Sex Outcome Treatment
    1