BEUDAMED
    FDA Adverse Event Other Summary report: N

    EASYPUMP

    MDR report key: 1080994 · Received July 23, 2008

    Report

    Report Number
    2026095-2008-00087
    Event Type
    Other
    Date Received
    July 23, 2008
    Date of Event
    June 1, 2008
    Report Date
    June 25, 2008
    Manufacturer
    I-FLOW CORPORATION
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY : THE INFO CONTAINED HEREIN IS BASED ON THE INFO PROVIDED BY THE INITIAL REPORTER. IT WAS REPORTED THAT THE PUMP INFUSED IN LESS THAT 24 HOURS INSTEAD OF THE EXPECTED 33 HOURS. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE INVOLVED IN THIS INCIDENT WAS DISCARDED; THEREFORE, OUR RESULTS AND CONCLUSION ARE BASED ON THE INFO THAT WAS PROVIDED TO I-FLOW BY THE INITIAL REPORTER. IN ADDITION, THE LOT NUMBER OF THE DEVICE WAS NOT KNOWN; THEREFORE, WE ARE UNABLE TO EVALUATE RETAIN DEVICES FOR POSSIBLE FAILURE ANALYSIS (I.E. FAST FLOW) OR RESEARCH THE LOT HISTORY FOR SIMILAR COMPLAINTS. NO OTHER INFO HAS BEEN RECEIVED. IF ADDITIONAL INFO THAT IS PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL REOPEN THE COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP INFUSED TOO QUICKLY. THE PUMP WAS FILLED TO 400 ML AND SET AT 12 ML PER HOUR. IT WAS STATED THAT THE PUMP SHOULD HAVE LASTED APPROXIMATELY 33 HOURS, BUT LASTED LESS THAN 24 HOURS. THE PUMP WAS DISCARDED BY CUSTOMER. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYPUMP INFUSION PUMP MEB I-FLOW CORPORATION CB004 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other