BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMEPUMP ECLIPSE, 400ML, 100ML/HR

    MDR report key: 2240873 · Received August 16, 2011

    Report

    Report Number
    2026095-2011-00214
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 18, 2011
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    K052117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: SAMPLE HAS NOT YET BEEN RECEIVED, BUT WAS REPORTED TO BE AVAILABLE. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) WAS CONDUCTED FOR THE LOT NUMBER AND INCIDENT REPORTED. THE DEVICE PASSED ALL MFG SPECS PRIOR TO RELEASE. INFO PROVIDED INDICATES THE PUMP WAS UNDER-FILLED TO 150ML, WHICH DOES FLOW FASTER THAN A NOMINALLY FILLED PUMP. THE DIRECTIONS FOR USE ((B)(4)) CONTAINS A CAUTION STATEMENT: FILLING THE PUMP LESS THAN NOMINAL RESULTS IN FASTER FLOW RATE. 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: LEVAQUIN. FILL VOLUME: 150ML AND FLOW RATE: 100ML/HR. PROCEDURE: INFECTION TREATMENT. CATHPLACE: DOUBLE LUMEN PICK, TYPICALLY IN ARM. DRUG INFUSED IN 55 MINUTES. NO HARM TO PT. PER DFU : NOMINAL FLOW RATE: 100ML/HR. NOMINAL FILL VOLUME: 400ML. MAXIMUM FILL VOLUME: 500ML. THE INFUSION DELIVERY TIME IS APPROX 1:35 HOURS WHEN FILLED TO NOMINAL VOLUME AND FLOW RATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMEPUMP ECLIPSE, 400ML, 100ML/HR ELASTOMERIC PUMP MEB I-FLOW CORP. E401000 142508

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR