BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP: LT 270-132:270 ML, 22ML/HR

    MDR report key: 4320404 · Received November 7, 2014

    Report

    Report Number
    2026095-2014-00225
    Event Type
    Malfunction
    Date Received
    November 7, 2014
    Date of Event
    July 2, 2014
    Report Date
    October 8, 2014
    Manufacturer
    I-FLOW LLC
    Product Code
    MEB
    PMA / PMN Number
    K052117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: IT WAS REPORTED THAT ALL 5 SUSPECT DEVICES WERE DISCARDED. THEREFORE, THE REPORTER RETURNED 5 REPRESENTATIVE SAMPLES FROM THE SAME LOT NUMBER FOR TESTING. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED FOR THE LOT NUMBER REPORTED. RESULTS: EVALUATION AND INVESTIGATION RESULTS WILL BE PROVIDED ONCE THEY ARE COMPLETED. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR THE LOT NUMBER OF THE MANUFACTURED UNIT. THERE WERE NO REWORKS, SPECIAL CONDITIONS, OR RELATED NON CONFORMANCE REPORTS (NCRS) FOR THIS LOT. THE LOT MET THE PROCESS SPECIFICATIONS, INCLUDING THE QUALITY CONTROL ACCEPTANCE CRITERIA PRIOR TO RELEASE. CONCLUSIONS: A CONCLUSION IS NOT YET AVAILABLE AS THE INVESTIGATION AND EVALUATION OF THE DEVICES IS STILL IN PROGRESS. ONCE THE INVESTIGATION AND DEVICE ANALYSIS ARE COMPLETED A FOLLOW-UP REPORT WILL BE SUBMITTED. INFORMATION FROM THIS INCIDENT HAS BEEN INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEMS. TREND INFORMATION IS USED TO IDENTIFY THE NEED FOR ADDITIONAL INVESTIGATIONS.

    Description of Event or Problem · 1

    FILL VOLUME: 330ML. FLOW RATE: 2ML/HR. PROCEDURE: CHEMOTHERAPY. CATHPLACE: RIGHT CHEST (PORT-A-CATH). REPORT 3 OF 5; PLEASE REFERENCE: 2026095-2014-00214/ (B)(4) (A), 2026095-2014-00224/(B)(4) (B), 2026095-2014-00226/(B)(4) (D), 2026095-2014-00227/(B)(4) (E). PUMP 3: AN INCIDENT INVOLVING ONE PATIENT WITH 5 INCIDENTS OF FAST FLOWS WERE REPORTED. THE INCIDENT WAS DESCRIBED AS "INFUSER FINISHED AHEAD OF SCHEDULE (IN THE SAME PATIENT)." IT WAS REPORTED THAT THE INFUSION ENDED 1 OR 2 DAYS EARLIER THAN EXPECTED. THE PATIENT REPORTED FATIGUE, NAUSEA AND MALAISE FOLLOWING THE INFUSIONS. AT THE TIME OF THIS REPORT, THE PATIENT WAS STILL UNDERGOING TREATMENT. THE PUMP WAS FILLED ON (B)(6) 2014 AND INFUSION WAS STARTED ON THE SAME DAY. THE INFUSION ENDED ON (B)(6) 2014 (2 DAYS), THIS IS WHEN THE DEFECT/INCIDENT WAS NOTICED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720833 EASYPUMP: LT 270-132:270 ML, 22ML/HR ELASTOMERIC PUMP MEB I-FLOW LLC 04434376 0201022114

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR DRUG: FLUORACILA 8.92ML DILUTED IN NORMAL SALINE