BEUDAMED
    FDA Adverse Event Other Summary report: N

    LT 270-24, EASYPUMP 270ML, 10ML/HR

    MDR report key: 2845039 · Received November 7, 2012

    Report

    Report Number
    2026095-2012-00264
    Event Type
    Other
    Date Received
    November 7, 2012
    Date of Event
    February 28, 2012
    Report Date
    October 10, 2012
    Manufacturer
    I-FLOW LLC
    Product Code
    MEB
    PMA / PMN Number
    K052117
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THREE SAMPLES WERE RETURNED FOR EVALUATION AND INVESTIGATION: TWO USED PUMPS AND ONE UNUSED PUMP IN ITS STERILE POUCH. A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED FOR THE LOT NUMBER REPORTED. THE DEVICE LOT MET MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. A VISUAL EXAMINATION WAS PERFORMED ON ALL THREE PUMPS. A FILL PRESSURE TEST WAS PERFORMED ON THE UNUSED SAMPLE. RESULTS: THE 2 USED PUMPS WERE RETURNED PARTIALLY FILLED AND WERE VISUALLY ASYMMETRICAL. A FILL PRESSURE TEST WAS PERFORMED ON THE UNUSED SAMPLE. IT FILLED ASYMMETRICALLY AND REQUIRED AN INITIAL FILL PRESSURE THAT EXCEEDS MAXIMUM ALLOWABLE PRESSURE. CONCLUSION: THE COMPLAINT OF ASYMMETRICAL FILLING IS CONFIRMED. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEM. ADDITIONAL INVESTIGATION MAY ARISE FROM ONGOING ANALYSIS, TREND INFORMATION, OR OTHER ANALYSIS AS APPROPRIATE. FILLING DIFFICULTY DOES NOT MEET THE CRITERIA FOR A REPORTABLE EVENT. I-FLOW IS FILING THIS REPORT IN RESPONSE TO AN EU VIGILANCE REPORT RECEIVED ON (B)(4) 2012.

    Description of Event or Problem · 1

    DRUG/DILUENT: BICARBONATE 1.4%, FILL VOLUME: 270ML, FLOW RATE: NA, PROCEDURE: NA, CATHPLACE: NA, ASYMMETRICAL FILLING. 3 PUMPS WERE RETURNED. 2 USED PUMPS AND 1 UNUSED PUMP IN ITS STERILE POUCH. ALL PUMPS WERE FROM LOT # 182248.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LT 270-24, EASYPUMP 270ML, 10ML/HR ELASTOMERIC PUMP MEB I-FLOW LLC 04434378 182248

    Patients

    Seq Age Sex Outcome Treatment
    1 NA