BEUDAMED
    FDA Adverse Event Other Summary report: N

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    MDR report key: 1355357 · Received March 30, 2009

    Report

    Report Number
    2026095-2009-00064
    Event Type
    Other
    Date Received
    March 30, 2009
    Date of Event
    February 25, 2009
    Report Date
    March 4, 2009
    Manufacturer
    I-FLOW CORPORATION
    Product Code
    MEB
    PMA / PMN Number
    K052117
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION CONTAINED HEREIN IS BASED ON THE INFORMATION PROVIDED BY THE INITIAL REPORTER. NO SAMPLE WAS AVAILABLE FOR EVALUATION AND INVESTIGATION. WITHOUT THE ACTUAL SAMPLE, A COMPLETE ANALYSIS CANNOT BE CONDUCTED. THE DEVICE HISTORY RECORD WAS REVIEWED FOR THE LOT AND ALL MANUFACTURING OPERATIONS WERE FOUND TO BE WITHIN SPECIFICATION. A REVIEW OF THE LOT HISTORY FOUND NO OTHER COMPLAINTS FOR THE REPORTED LOT NUMBER. NO DETERMINATION COULD BE MADE AS TO WHY THE PUMP APPEARED TO FLOW FAST. IT WAS REPORTED THAT THE ANESTHESIOLOGIST LATER TESTED THE FLOW ACCURACY OF THE DEVICE AND STATED THAT THERE WAS NO PROBLEM WITH THE FLOW RATE. IF ADDITIONAL INFORMATION THAT IS PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL OPEN THE COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INFUSION WAS COMPLETED IN 24 HOURS INSTEAD OF 48 HOURS. IN EVENING ON DAY OF SURGERY, THE PATIENT FELL DOWN IN HOSPITAL'S RESTROOM WITH A BLOOD PRESSURE OF 60 MMHG. IT WAS STATED THAT THE PUMP WAS EMPTY. FILL VOLUME 100ML. PUMP IS BEING RETAINED BY CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMEPUMP ECLIPSE C-SERIES INFUSION PUMP MEB I-FLOW CORPORATION C100020 842625

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R