BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3964663 · Received May 30, 2014

    Report

    Report Number
    2026095-2014-00071
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Report Date
    May 5, 2014
    Manufacturer
    I-FLOW, LLC
    Product Code
    MEB
    PMA / PMN Number
    K052117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE WAS RECEIVED FOR AN EVALUATION AND INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) WAS CONDUCTED FOR THE LOT NUMBER REPORTED. RESULTS: AT THIS TIME TESTING IS IN PROGRESS, ONCE THE INVESTIGATION IS COMPLETED THE RESULTS WILL BE PROVIDED. PER THE DHR THERE WERE NO REWORKS, SPECIAL CONDITIONS, OR RELATED NONCONFORMANCE REPORTS (NCRS) FOR THIS LOT. THE LOT MET THE PROCESS SPECIFICATIONS, INCLUDING THE QUALITY CONTROL ACCEPTANCE CRITERIA PRIOR TO RELEASE. CONCLUSION: THE INVESTIGATION AND EVALUATION ARE ONGOING, ONCE COMPLETED A FOLLOW-UP REPORT WILL BE SUBMITTED. 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

    FILL VOLUME: 100.00. FLOW RATE: 2.0 ML/HR. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. THE DISTRIBUTOR REPORTED A FAST FLOW OF A USED EASYPUMP. PATIENT CONTACT IS UNKNOWN, THE DATE OF EVENT WAS NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320005 EASYPUMP: LT 100-48: 100 ML, 2ML/HR ELASTOMERIC PUMP MEB I-FLOW, LLC 04434370 0201029832

    Patients

    Seq Age Sex Outcome Treatment
    1