BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP: LT 270-54:270ML, 5ML/HR

    MDR report key: 4213996 · Received October 24, 2014

    Report

    Report Number
    2026095-2014-00236
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Report Date
    September 30, 2014
    Manufacturer
    I-FLOW, LLC,
    Product Code
    MEB
    PMA / PMN Number
    K052117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: AN UNUSED DEVICE WITH THE SAME LOT NUMBER 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 NON CONFORMANCE REPORTS (NCR) FOR THIS LOT. THE LOT MET THE PROCESS SPECIFICATIONS, INCLUDING THE QUALITY CONTROL ACCEPTANCE CRITERIA PRIOR TO RELEASE. CONCLUSIONS: THE INVESTIGATION AND EVALUATION ARE ONGOING, 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, FLOW RATE: 5 ML/HR, PROCEDURE: UNK, CATHPLACE: UNK. THIS IS REPORT 2 OF 4; PLEASE REFERENCE: 2026095-2014-00203/14-00858(A), 2026095-2014-00204/14-00858(B), 2026095-2014-00237/14-00858(D). PUMP 2 OF 3. IT WAS REPORTED THAT THE PUMP WAS EXPECTED TO FINISH INFUSION IN 46 HOURS, BUT EXCEEDED THE ESTIMATED TIME BY 15%. IT WAS REPORTED THAT THE PUMP FINISHED 7 HOURS BEFORE ITS EXPECTED TIME. THERE WERE NO REPORTS OF PATIENT INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678913 EASYPUMP: LT 270-54:270ML, 5ML/HR ELASTOMERIC PUMP MEB I-FLOW, LLC, 04438043 0200486668

    Patients

    Seq Age Sex Outcome Treatment
    1