BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP: LT 100-48:100ML, 2ML/HR

    MDR report key: 4320435 · Received November 7, 2014

    Report

    Report Number
    2026095-2014-00219
    Event Type
    Malfunction
    Date Received
    November 7, 2014
    Report Date
    October 8, 2014
    Manufacturer
    I-FLOW, LLC
    Product Code
    MEB
    PMA / PMN Number
    K052117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE WAS RECEIVED FOR ANALYSIS, EVALUATION OF THE DEVICE IS ANTICIPATED BUT NOT YET BEGUN. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED FOR THE REPORTED LOT NUMBER. RESULTS: PER THE DHR REVIEW THERE WERE NO REWORKS, SPECIAL CONDITIONS, OR RELATED NON CONFORMANCE REPORTS (NCRS) FOR THIS LOT. THE LOT MET THE PROCESS SPECIFICATIONS, INCLUDING THE QUALITY CONTROL ACCEPTANCE CRITERIA PRIOR TO RELEASE. EVALUATION AND INVESTIGATION RESULTS WILL BE PROVIDED ONCE THEY ARE COMPLETED. CONCLUSIONS: A CONCLUSION IS NOT YET AVAILABLE AS THE INVESTIGATION AND EVALUATION OF THE PRODUCT IS STILL IN PROGRESS. ONCE COMPLETED A FOLLOW-UP REPORT WILL BE SUBMITTED. INFORMATION FROM THIS INCIDENT HAS BEEN INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEMS. TREND INFORMATION IS USED TO IDENTIFY THE NEED FOR ADDITIONAL INVESTIGATIONS.

    Description of Event or Problem · 1

    FILL VOLUME: UNK-ANP. FLOW RATE: UNK-ANP. PROCEDURE: UNK-ANP, CATHPLACE: UNK-ANP. REPORT 4 OF 6; PLEASE REFERENCE: 2026095-2014-00210/14-00880 (A), 2026095-2014-00217/14-00880 (B), 2026095-2014-00218/14-00880 (C), 2026095-2014-00220/14-00880 (E), 2026095-2014-00221/14-00880 (F). PUMP 4: IT WAS REPORTED BY OUR PRODUCT DISTRIBUTOR THAT THERE WERE 6 INCIDENTS REPORTED OF FASTER FLOW WHILE USING EASYPUMPS. THE INCIDENT WAS DESCRIBED AS "PUMP-FLOW RATE-FAST, FUNCTION - TOO HIGH." THE DATE OF INCIDENT AND PATIENT INFORMATION WERE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720719 EASYPUMP: LT 100-48:100ML, 2ML/HR ELASTOMERIC PUMP MEB I-FLOW, LLC 04434370 0200920723

    Patients

    Seq Age Sex Outcome Treatment
    1 DRUG: UNK - ANP