BEUDAMED
    FDA Adverse Event Other Summary report: N

    EASYPUMP

    MDR report key: 1193526 · Received October 7, 2008

    Report

    Report Number
    2026095-2008-00169
    Event Type
    Other
    Date Received
    October 7, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 8, 2008
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION CONTAINED HEREIN IS BASED ON THE INFORMATION PROVIDED BY THE INITIAL REPORTER AND THE EVALUATION OF THE SAMPLE. ONE EMPTY AND USED PUMP WAS RECEIVED FOR EVALUATION AND INVESTIGATION. THE VISUAL INSPECTION OF THE PUMP FOUND DRY MEDICATION AT THE DISTAL LUER. THE PUMP WAS REFILLED WITH NORMAL SALINE SOLUTION TO THE REPORTED FILL VOLUME OF 96ML. WHEN THE PINCH CLAMP WAS OPENED, THE PUMP DID NOT INFUSE. THE TUBING AND FLOW RESTRICTOR WERE PLACED IN WARM WATER AND CONNECTED TO AN AIR SOURCE FOR ABOUT 24 HOURS. THE PUMP WITHOUT TUBING INFUSED. THE TUBING WAS RECONNECTED TO THE PUMP AND A FLOW RATE ACCURACY TEST WAS PERFORMED. THE FLOW RATE WAS FOUND TO BE SLOW DUE TO THE DRY MEDICATION IN THE TUBING AND FLOW RESTRICTOR. RETAIN SAMPLES FROM LOT 832416 WERE EVALUATED AND DID NOT CONFIRM A RAPID FLOW RATE. A REVIEW OF THE LOT HISTORY FOUND THIS TO BE THE ONLY FAST FLOW COMPLAINT FOR THE LOT. WE REVIEWED OUR DEVICE HISTORY RECORD, 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

    FLOW RATE TOO FAST. FILL VOLUME 96ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYPUMP INFUSION PUMP MEB I-FLOW CORP. LT 100-48 832416

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other