BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMEPUMP ECLIPSE 400ML, 100ML/HR

    MDR report key: 4102692 · Received August 28, 2014

    Report

    Report Number
    2026095-2014-00157
    Event Type
    Malfunction
    Date Received
    August 28, 2014
    Date of Event
    July 15, 2014
    Report Date
    July 31, 2014
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    K052117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE WAS REPORTED NOT TO BE RETURNING FOR ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED FOR THE LOT NUMBER REPORTED, ALONG WITH A REVIEW OF THE INSTRUCTIONS FOR USE (IFU). RESULTS: THE DEVICE MET ALL SPECIFICATIONS AT RELEASE. AS A DEVICE WAS NOT AVAILABLE FOR AN EVALUATION, NO METHODS WERE PERFORMED; THEREFORE, RESULTS CANNOT BE OBTAINED. CONCLUSION: A DEVICE EVALUATION COULD NOT BE CONDUCTED AS THE DEVICE WAS REPORTED TO NOT BE RETURNING. BASED ON THE REPORTED INCIDENT INFORMATION THE DEVICE WAS FILLED AND INFUSION WAS STARTED ON (B)(6) 2014 AT 08:00 AND COMPLETED ON THE SAME DAY AT 11:00AM. ACCORDING WITH THE INFORMATION REPORTED, THE USER DID NOT WAIT THE FOUR HOURS AS REQUIRED BY THE INSTRUCTION FOR USE. 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: 400 ML. FLOW RATE: 100ML/HR. PROCEDURE: THERAPY CATHPLACE: PERIPHERAL IV IN ARM. IT WAS REPORTED THAT A FEMALE PATIENT EXPERIENCED A FAST FLOW WHILE USING A PUMP. THE INCIDENT OCCURRED (B)(6) 2014 AND IT WAS INITIALLY REPORTED THAT "INFUSION OF THE CORTICOIDS INFUSED WITHIN 2 HOURS INSTEAD OF 4 HOURS." ADDITIONAL INFORMATION WAS RECEIVED THAT THE INFUSION WAS STARTED ON (B)(6) 2014 AT 08:00 VIA A PERIPHERAL IV AND COMPLETED ON THE SAME DAY AT 11:00. THIS INCIDENT WAS NOTICED BY THE PATIENT AND THE PUMP WAS REPORTED TO BE EMPTY AT THE END OF THE INFUSION. THE PATIENT WAS REPORTED TO HAVE HYPOTENSION AND ASTHENIA. NO MEDICAL INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526667 HOMEPUMP ECLIPSE 400ML, 100ML/HR ELASTOMERIC PUMP MEB I-FLOW CORP. E401000-10 0200983842

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR DRUG: 1G OF SOLUMEDROL IN GLUCOSE 0,5%,| 30MM/20G KELIS MED CATHETER.