BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYPUMP: LT 270-132: 270 ML, 2 ML/HR

    MDR report key: 3391200 · Received October 3, 2013

    Report

    Report Number
    2026095-2013-00150
    Event Type
    Injury
    Date Received
    October 3, 2013
    Date of Event
    June 27, 2013
    Report Date
    September 4, 2013
    Manufacturer
    I-FLOW, LLC
    Product Code
    MEB
    PMA / PMN Number
    K052117
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: AT THIS TIME THE MANUFACTURER IS PENDING RETURN OF THE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORDS WAS CONDUCTED. RESULTS: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED FOR THE LOT NUMBER PROVIDED, AND THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. CONCLUSIONS: WHEN THE SAMPLE IS RETURNED IT WILL BE EVALUATED AND INVESTIGATED AND A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE. 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: FLUOROURACIL 50 MG/ML DILUTED WITH DEXTROSE. FILL VOLUME: 92 ML. FLOW RATE: 2 ML/HR. PROCEDURE: CHEMOTHERAPY. CATHPLACE: IV - PORT. A FAST FLOW WAS REPORTED, PUMP WAS EXPECTED TO FLOW FOR 46 HOURS BUT COMPLETED IN 19 HOURS. THE PHARMACIST BELIEVES THAT THE INFUSER LABELED WITH 2 ML/HR WAS IN REALITY A 5 MG/HR PRODUCT. THE PT NOTICED THE OCCURRENCE AND WENT TO THE HOSPITAL TO REMOVE THE INFUSER. PT WAS GIVEN GRANULOKINE TO COMPENSATE NEUTROPENIA. DATE PUMP FILLED: (B)(6) 2013. DATE INFUSION STARTED: (B)(6) 2013 TIME WAS NOT PROVIDED. DATE INFUSION ENDED: (B)(6) 2013 TIME WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500869 EASYPUMP: LT 270-132: 270 ML, 2 ML/HR ELASTOMERIC PUMP MEB I-FLOW, LLC 04434376 0200531647

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other