BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP

    MDR report key: 2021368 · Received February 8, 2011

    Report

    Report Number
    2026095-2011-00016
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    December 2, 2010
    Report Date
    January 10, 2011
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    K052117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: SAMPLE HAS NOT YET BEEN RECEIVED, BUT WAS REPORTED TO BE AVAILABLE. 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. RESULTS: WITHOUT THE ACTUAL PRODUCT, AN ANALYSIS CANNOT BE CONDUCTED. CONCLUSION: A FOLLOW-UP REPORT WILL BE FILED WHEN INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    FAST FLOW (DRUG/DILUENT: 5FU, 3480MG), (FILL VOLUME:125ML) (FLOW RATE: 5ML/HR). PATIENT NOTICED PUMP INFUSED IN 2 HOURS INSTEAD OF 25 HOURS. STARTED INFUSION (B)(6) 2010 AT 6 AM. FINISHED INFUSING (B)(6) 2010 AT 8 AM. PER DFU: THE NOMINAL FILL VOLUME: 125ML; FLOW RATE: 5ML/HR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYPUMP ELASTOMERIC PUMP MEB I-FLOW CORP. LT 125-24 022537

    Patients

    Seq Age Sex Outcome Treatment
    1