BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMEPUMP ECLIPSE: 400ML, 100ML/HR

    MDR report key: 4239259 · Received October 31, 2014

    Report

    Report Number
    2026095-2014-00208
    Event Type
    Malfunction
    Date Received
    October 31, 2014
    Date of Event
    September 30, 2014
    Report Date
    October 3, 2014
    Manufacturer
    I-FLOW, LLC
    Product Code
    MEB
    PMA / PMN Number
    K052117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE WAS REPORTED NOT TO BE AVAILABLE FOR EVAL AND ANALYSIS. AS THE LOT NUMBER IS NOT KNOWN, A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CANNOT BE CONDUCTED. RESULTS: AS THE DEVICE AND LOT NUMBER WERE UNAVAILABLE FOR ANALYSIS, NO METHODS WERE PERFORMED. FOR THIS REASON RESULTS CANNOT BE OBTAINED. CONCLUSIONS: THE DEVICE WAS NOT RETURNED TO I-FLOW FOR EVAL, THEREFORE WE ARE UNABLE TO DETERMINE THE CAUSE FOR THE REPORTED EVENT. LIMITED INFO WAS PROVIDED BY THE REPORTER; THEREFORE, FURTHER INFO HAS BEEN REQUESTED BUT NOT YET RECEIVED. IF ADD'L INFO PERTINENT TO THIS COMPLAINT IS RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED. INFO FROM THIS INCIDENT HAS BEEN INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEMS. TREND INFO IS USED TO IDENTIFY THE NEED FOR ADD'L INVESTIGATIONS.

    Description of Event or Problem · 1

    FILL VOLUME: 400ML. FLOW RATE: 100ML/HR. PROCEDURE: IV SOLUMEDRAL INFUSION. CATHPLACE: IV. THIS IS REPORT 2 OF 6; PLEASE REFERENCE: 2026095-2014-00206/14-00867 (A), 2026095-2014-00238/14-00867 (C), 2026095-2014-00239/14-00867 (D), 2026095-2014-00240/14/00867 (E), 2026095-2014-00241/14-00867 (F). PT 2, PUMP 1 OF 5. IT WAS REPORTED BY A PHARMACIST THAT 6 INCIDENTS OF FAST FLOW OCCURRED DURING INFUSION OF SOLUMEDRAL WITH 6 INDIVIDUAL HOMEPUMPS AND TWO PTS. FOR PT 2, THERE WERE A TOTAL OF 5 PUMPS, EACH ONE WAS USED DAILY AND IT WAS REPORTED THAT EACH ONE RAN IN ABOUT 3 HOURS. NO PT CONSEQUENCES WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698209 HOMEPUMP ECLIPSE: 400ML, 100ML/HR ELASTOMERIC PUMP MEB I-FLOW, LLC E401000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR DRUG: SOLUMEDRAL