BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMEPUMP ECLIPSE: 400 ML, 100 ML/HR

    MDR report key: 3043052 · Received March 7, 2013

    Report

    Report Number
    2026095-2013-00040
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    January 1, 2013
    Report Date
    February 5, 2013
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    K052117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE SAMPLE WILL NOT BE RETURNED FOR EVAL AND INVESTIGATION. RESULTS: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED FOR THE LOT NUMBER PROVIDED, AND THE DEVICE PASSED ALL MFG SPECIFICATIONS PRIOR TO RELEASE. CONCLUSIONS: THE DEVICE IS UNAVAILABLE TO EVALUATE AND INVESTIGATE; THEREFORE I-FLOW IS UNABLE TO DETERMINE A CONCLUSION THAT THE DEVICE IN QUESTION PERFORMED AS INTENDED AS THIS DEVICE WAS TESTED BY THE END USER. I-FLOW WAS NOT PROVIDED WITH THE TESTING RESULTS OR INFO ON HOW THE DEVICE WAS TESTED, AS WELL AS HOW THE CONCLUSION OF FAST FLOW WAS DRAWN BASED ON THEIR TESTING RESULTS. ALTHOUGH AN INVESTIGATION FOR THIS INCIDENT COULD NOT BE PERFORMED, I-FLOW IS CONDUCTING FURTHER INVESTIGATIONS INTO THE DEFECT TYPE ¿FAST FLOW¿ FOR CONFIRMED AND UNCONFIRMED. INFO FROM THIS INCIDENT HAS BEEN INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEM. I-FLOW PROVIDES A ¿CAUTIONS¿ IN ITS DFU WHICH STATES THE FOLLOWING: ACTUAL INFUSION TIMES MAY VARY DUE TO THE FOLLOWING: FILLING THE PUMP LESS THAN NOMINAL RESULTS IN FASTER FLOW RATE. FILLING THE PUMP MORE THAN NOMINAL RESULTS IN SLOWER FLOW RATE. TEMPERATURE WILL AFFECT SOLUTION VISCOSITY, RESULTING IN SHORTER OR LONGER DELIVERY TIME. THE HOMEPUMP ECLIPSE IS DESIGNED TO BE USED AT ROOM TEMP (20 DEGREES CELSIUS/ 68 DEGREES FAHRENHEIT). IF THE HOMEPUMP ECLIPSE OR ITS TUBING IS AT 25 DEGREES CELSIUS/78 DEGREES FAHRENHEIT, THE FLOW RATE WILL INCREASE APPROX. THE 14% ABOVE ITS NOMINAL RATE; AT 15 DEGREES CELSIUS/60 DEGREES FAHRENHEIT, THE FLOW RATE WILL DECREASE APPROX. 12% BELOW IT NOMINAL RATE. THE HOMEPUMP ECLIPSE AND TUBING SHOULD BE WORN OUTSIDE THE CLOTHING. THE HOMEPUMP ECLIPSE MUST BE FILLED 4 HOURS PRIOR TO ADMINISTRATION TO INFUSE AT THE LABELED FLOW RATE. IF THE HOMEPUMP ECLIPSE IS USED IMMEDIATELY AFTER FILLING, FLOW RATE MAY INCREASE BY UP TO 50%.

    Description of Event or Problem · 1

    DRUG/DILUENT: SODIUM CHLORIDE 0.9%. FILL VOLUME: 400 ML. FLOW RATE: 100 ML/HR. PROCEDURE: N/A ¿ TEST PUMP. CATHPLACE: N/A. (REFERENCE 2026095-2013-00039/13-00185, 2026095-2013-00040/13-00184, AND 2026095-2013-00041/13-00187). THERE WAS NO PATIENT CONTACT, CUSTOMER REPORTED PUMP INFUSED AN HOUR EARLIER THAN IT WAS SUPPOSED TO. THIS REPORTED PUMP WAS A TEST PUMP. IT WAS TESTED BY THE END USER AT THEIR FACILITY DUE TO A PT COMPLAINT OF FAST FLOW FOR REFERENCE NUMBER: 2026095-2013-00185.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98479 HOMEPUMP ECLIPSE: 400 ML, 100 ML/HR ELASTOMERIC PUMP MEB I-FLOW CORP. E401000 0200547658

    Patients

    Seq Age Sex Outcome Treatment
    1 NA