BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMEPUMP C-SERIS: 100 ML, 2 ML/HR

    MDR report key: 3967175 · Received June 24, 2014

    Report

    Report Number
    2026095-2014-00102
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Report Date
    May 29, 2014
    Manufacturer
    I-FLOW, LLC
    Product Code
    MEB
    PMA / PMN Number
    K052117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE WAS NOT AVAILABLE FOR RETURN, THEREFORE NO TESTING METHODS WERE PERFORMED. AS NO LOT NUMBER WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED. RESULTS: AS A DEVICE AND LOT NUMBER WAS UNAVAILABLE FOR AN EVAL, NO METHODS WERE PERFORMED. FOR THIS REASON RESULTS CANNOT BE OBTAINED. CONCLUSIONS: BASED ON THE LIMITED INFO RECEIVED REGARDING THE REPORTED INCIDENT AND THE DEVICE NOT AVAILABLE FOR EVAL, WE ARE UNABLE TO DETERMINE A CAUSE FOR THE REPORTED EVENT. IF ADD'L INFO PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A FOLLOW UP REPORT. INFO FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEM. ADD'L INVESTIGATION MAY ARISE FROM ONGOING ANALYSIS, TREND INFO, OR OTHER ANALYSIS AS APPROPRIATE.

    Description of Event or Problem · 1

    FILL VOLUME: 230 ML/HR. FLOW RATE: 2 ML. PROCEDURE: CHEMOTHERAPY TREATMENT. CATHPLACE: IV. {PLEASE REF 2026095-2014-00103/(B)(4)} A FAST FLOW WAS DOCUMENTED IN A PUMP PRODUCT TRIAL REPORT. THE STATEMENT IN THE REPORT READ "4 DAY PUMP THAT APPEARED TO HAVE CLOSE TO EMPTIED BY DAY 3". ADD'L INFO RECEIVED ON (B)(4) 2014, THE INCIDENT WAS REPORTED TO THE NURSE BY A PT IN THE TRIAL. THE PUMP WAS USED FOR 5FU INFUSION. AS PER THE CUSTOMER, THIS WAS AN ANONYMOUS PRODUCT TRIAL, NO FURTHER INFO CAN BE RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367164 HOMEPUMP C-SERIS: 100 ML, 2 ML/HR ELASTOMERIC PUMP MEB I-FLOW, LLC C100020 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 DRUG: 5FU