BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMEPUMP C-SERIES: 270 ML, 5 ML/HR

    MDR report key: 3172383 · Received June 5, 2013

    Report

    Report Number
    2026095-2013-00104
    Event Type
    Malfunction
    Date Received
    June 5, 2013
    Date of Event
    April 26, 2013
    Report Date
    May 8, 2013
    Manufacturer
    I-FLOW, LLC.
    Product Code
    MEB
    PMA / PMN Number
    K052117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR AN EVALUATION AND INVESTIGATION. THE DEVICE EVALUATION IS ANTICIPATED, BUT NOT YET BEGUN. RESULTS: 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. CONCLUSION: A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION HAS BEEN COMPLETED. 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

    DRUG/DILUENT: 5FU; FILL VOLUME: 223 ML; FLOW RATE: 2.0 ML/HR; PROCEDURE: CHEMOTHERAPY TREATMENT; CATHPLACE: IV. PATIENT REPORTED HIS PUMP WAS EMPTY WHEN HE WOKE UP. THE PUMP SHOULD HAVE FINISHED AT 5:00 PM (DATE NOT STATED). THE PUMP APPEARED TO BE EMPTY WHEN THE PATIENT RETURNED TO THE FACILITY FOR DISCONNECTION. THE PUMP WAS PLACED IN A BAG FOR PICK UP AND THE BAG APPEARED TO HAVE A SMALL AMOUNT OF FLUID IN IT. NO ADVERSE EVENT REPORTED. START OF INFUSION WAS ON (B)(6) 2013 AT 16:10 PM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249411 HOMEPUMP C-SERIES: 270 ML, 5 ML/HR ELASTOMERIC PUMP MEB I-FLOW, LLC. C270020 142594

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR