BEUDAMED
    FDA Adverse Event Other Summary report: N

    EASYPUMP

    MDR report key: 1178152 · Received September 24, 2008

    Report

    Report Number
    2026095-2008-00159
    Event Type
    Other
    Date Received
    September 24, 2008
    Date of Event
    July 1, 2008
    Report Date
    August 26, 2008
    Manufacturer
    I-FLOW CORPORATION
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION CONTAINED HEREIN IS BASED ON THE EVALUATION OF THE SAMPLE. THE REPORT STATED THAT THE PUMP INFUSED TOO QUICKLY. ONE EMPTY AND USED PUMP WAS RECEIVED FOR EVALUATION AND INVESTIGATION. THE PUMP WAS REFILLED WITH NORMAL SALINE SOLUTION TO THE REPORTED FILL VOLUME OF 240 ML AND A FLOW RATE ACCURACY TEST WAS CONDUCTED. THE PUMP INFUSED WITHIN SPECIFICATIONS. THE DIRECTIONS FOR USE (DFU) (1303046, REV. E) CONTAINS A CAUTION FOR UNDERFILLING THE PUMP: "CAUTIONS: ACTUAL INFUSION TIMES MAY VARY DUE TO THE FOLLOWING: FILLING THE PUMP LESS THAN NOMINAL RESULTS IN FASTER FLOW RATE." THE DELIVERY TIMES PROVIDED IN THE DFU ARE APPROXIMATE WHEN PUMP IS FILLED TO A VOLUME OTHER THAN NOMINAL. A REVIEW OF LOT 832441 HISTORY FOUND NO CONFIRMED FLOW RATE COMPLAINTS FOR THIS LOT. THE DEVICE HISTORY RECORD WAS REVIEWED AND ALL MANUFACTURING OPERATIONS WERE FOUND TO BE WITHIN SPECIFICATION. PRODUCT COMPLAINT IS NOT CONFIRMED FOR FAST FLOW. IF ADDITIONAL INFORMATION IS RECEIVED PERTINENT TO THIS INCIDENT, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE REPORT STATED THAT FLOW RATE WAS TOO FAST. INFUSED IN 17 HOURS INSTEAD OF 23 HOURS. THE FILL VOLUME WAS 240 ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYPUMP INFUSION PUMP MEB I-FLOW CORPORATION 04434378 832441

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other