BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMEPUMP ECLIPSE: 400 ML, 100 ML/HR

    MDR report key: 3999058 · Received July 9, 2014

    Report

    Report Number
    2026095-2014-00118
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Report Date
    June 12, 2014
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    K052117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: AT THIS TIME ONLY ONE DEVICE HAS BEEN RECEIVED FOR AN ANALYSIS. WE ARE CURRENTLY PENDING THE RETURN OF THIS DEVICE. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) WAS PERFORMED FOR THE LOT NUMBER PROVIDED. RESULTS: AT THIS TIME THE EVALUATION IS STILL IN PROGRESS. RESULTS WILL BE PROVIDED ONCE COMPLETED. PER THE DHR REVIEW, THERE WERE NO REWORKS, SPECIAL CONDITIONS, OR RELATED NONCONFORMANCE REPORTS (NCRS) FOR THIS LOT. THE LOT MET THE PROCESS SPECIFICATIONS AT RELEASE. CONCLUSIONS: I-FLOW IS AWAITING THE RETURN OF THE TWO ADDITIONAL DEVICES THAT WERE REPORTED TO BE AVAILABLE FOR ANALYSIS. THE INVESTIGATION IS ONGOING, ONCE COMPLETED A FOLLOW UP REPORT WILL BE SUBMITTED. 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.

    Description of Event or Problem · 1

    FILL VOLUME: UNKNOWN. FLOW RATE: 100 ML/HR. PROCEDURE: UNKNOWN - ANP. CATHPLACE: UNKNOWN. PATIENT 2 OF 3. PLEASE REFERENCE 2026095-2014-00117/14-00495 (A), 2026095-2014-00119/14-00495 (C). IT WAS REPORTED THAT THREE PATIENTS EXPERIENCED FAST FLOWS WHILE USING A E401000 PUMP. THE NURSE DID NOT WAIT THE 4 HOURS BETWEEN FILLING THE PUMP AND INFUSION. PATIENT TWO'S PUMP INFUSED SOLU-MEDROL IN 2.5 HOURS INSTEAD OF THE EXPECTED 4 HOURS. ANP: ASKED NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399222 HOMEPUMP ECLIPSE: 400 ML, 100 ML/HR ELASTOMERIC PUMP MEB I-FLOW CORP. E401000 0200974832

    Patients

    Seq Age Sex Outcome Treatment
    1 DRUG: SOLU-MEDROL LG DILUTED IN 400ML OF G5%