BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LT 270-54, EASYPUMP, 270 ML, 5 ML/HR

    MDR report key: 2837624 · Received November 7, 2012

    Report

    Report Number
    2026095-2012-00269
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    September 1, 2012
    Report Date
    October 9, 2012
    Manufacturer
    I-FLOW, LLC
    Product Code
    MEB
    PMA / PMN Number
    K052117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THREE (3) EMPTY AND USED SAMPLES WERE RECEIVED FOR INSPECTION AND EVALUATION. ALL THREE (3) SAMPLES WERE OF THE SAME MODEL AND LOT NUMBER. RESULTS: THE DEVICES ARE CURRENTLY BEING TESTED AND EVALUATED AT THIS TIME. CONCLUSIONS: A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION HAS BEEN COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) WAS CONDUCTED FOR THE LOT NUMBER AND INCIDENT REPORTED. THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEM. ADDITIONAL INVESTIGATION MAY ARISE FROM ONGOING ANALYSIS, TREND INFORMATION, OR OTHER ANALYSIS AS APPROPRIATE.

    Description of Event or Problem · 1

    DRUG/DILUENT: 5FU. FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN. PROCEDURE: CHEMOTHERAPY. CATHPLACE: UNKNOWN. REFERENCE: (B)(4). AKH, (B)(6). B. BRAUN (B)(6) REPORTED A FAST FLOW AND THAT THE INFUSION FINISHED 6 HOURS EARLIER. NO ADVERSE EVENT. QUANTITY OF TWO (2) PUMPS REPORTED TO BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LT 270-54, EASYPUMP, 270 ML, 5 ML/HR ELASTOMERIC PUMP MEB I-FLOW, LLC 04438043 0200520350

    Patients

    Seq Age Sex Outcome Treatment
    1