BEUDAMED
    FDA Adverse Event Other Summary report: N

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    MDR report key: 1971948 · Received January 24, 2011

    Report

    Report Number
    2026095-2011-00009
    Event Type
    Other
    Date Received
    January 24, 2011
    Date of Event
    December 30, 2010
    Report Date
    January 5, 2011
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    K052117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE HAS NOT YET BEEN RECEIVED, BUT WAS REPORTED TO BE AVAILABLE. THE SAMPLE WILL BE EVALUATED WHEN RECEIVED AND FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    PATIENT NOTICED THAT PUMP INFUSED TOO FAST; INFUSED IN 12 HOURS INSTEAD OF 24. FILL VOLUME OF 48.2 ML IS LESS THAN RECOMMENDATION. NO ADVERSE EVENT OCCURRED. DATE OF EVENT: (B)(6), 2010. ANP: ASKED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMEPUMP C-SERIES ELASTOMERIC PUMP MEB I-FLOW CORP. C100020 972638

    Patients

    Seq Age Sex Outcome Treatment
    1