BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOMEPUMP ECLIPSE: 100 ML, 200 ML/HR

    MDR report key: 2625725 · Received June 14, 2012

    Report

    Report Number
    2026095-2012-00165
    Event Type
    Other
    Date Received
    June 14, 2012
    Date of Event
    January 1, 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
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - THE SAMPLE HAS BEEN RECEIVED BY THE REPORTER FOR INSPECTION AND EVALUATION. RESULTS - THE DEVICE IS PENDING EVALUATION AND TESTING AT THIS TIME. CONCLUSIONS - THE SAMPLE WILL BE EVALUATED AND A FOLLOW-UP REPORT WILL BE FILED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED FOR THE LOT NUMBER PROVIDED, AND THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE.

    Description of Event or Problem · 1

    DRUG/DILUENT: MEROPENEM 1200MG/120ML NACL 0.9%. FILL VOLUME: 120 ML. FLOW RATE: 200 ML/HR. PROCEDURE: NOT APPLICABLE. CATHPLACE: NOT APPLICABLE. FRESENIUS IN (B)(6) REPORTED THAT AN ECLIPSE PUMP HAD BLACK PARTICLES INSIDE. INFUSION OF THE PUMP WAS NOT STARTED. PT RECEIVED PUMP ON (B)(6) 2012, AND REPORTED THE ISSUE TO FRESENIUS (B)(4) 2012. NO ADVERSE EVENT REPORTED. NO INJURY TO PT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMEPUMP ECLIPSE: 100 ML, 200 ML/HR ELASTOMERIC PUMP MEB I-FLOW LLC SE102000 182299

    Patients

    Seq Age Sex Outcome Treatment
    1