BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ST 400-4, EASYPUMP, 400ML, 100 ML/HR

    MDR report key: 2619533 · Received June 13, 2012

    Report

    Report Number
    2026095-2012-00154
    Event Type
    Malfunction
    Date Received
    June 13, 2012
    Date of Event
    April 20, 2012
    Report Date
    May 16, 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: SAMPLE HAS NOT YET BEEN RECEIVED, BUT WAS REPORTED TO BE AVAILABLE. RESULTS: WITHOUT THE ACTUAL PRODUCT, AN ANALYSIS CANNOT BE CONDUCTED. CONCLUSIONS: THE SAMPLE WILL BE EVALUATED WHEN RECEIVED AND A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    DRUG/DILUENT: SOLUMEDROL 1GR. FILL VOLUME: 250 ML. FLOW RATE: 100 ML/HR. PROCEDURE: UNK. CATHPLACE: NOT APPLICABLE. THERAPY: IV INFUSION. (B)(6). FAST FLOW, THE PUMP INFUSED IN 1 HOUR 15MIN INSTEAD OF 2 HOURS. START DATE/TIME OF INFUSION (B)(6) 2012, 1:00 PM. END DATE/TIME OF INFUSION: (B)(6) 2012, 2:30 PM. PT CONTACT: YES. ADVERSE EVENT: NO. MEDICAL INTERVENTION: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST 400-4, EASYPUMP, 400ML, 100 ML/HR ELASTOMERIC PUMP MEB I-FLOW, LLC 04434360 192450

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR