BEUDAMED
    FDA Adverse Event Other Summary report: N

    EASYPUMP

    MDR report key: 1880561 · Received October 20, 2010

    Report

    Report Number
    2026095-2010-00262
    Event Type
    Other
    Date Received
    October 20, 2010
    Date of Event
    March 15, 2010
    Report Date
    September 27, 2010
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    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 A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    PUMP FILLED AT 12:30 AM, SAF SET AT 4 ML/HR. INFUSION STARTED AT 1 PM. PT IN RECOVERY UNTIL 5 PM, NO ISSUES WITH PUMP WERE IDENTIFIED. NEXT DAY AT 9 AM, THE PUMP WAS FOUND EMPTY. SAF WAS FOUND SET AT 8 ML/HR. INFUSED THE 400 ML IN APPROXIMATELY 20 HOURS. NO ADVERSE EVENT OCCURRED. OCCURRED 2 TIMES, BUT ONLY 1 PUMP WAS SAVED. DATE OF EVENT: (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYPUMP ELASTOMERIC PUMP MEB I-FLOW CORP. 4440008 992788

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK