BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUFLO

    MDR report key: 4840969 · Received June 12, 2015

    Report

    Report Number
    9610825-2015-00215
    Event Type
    Malfunction
    Date Received
    June 12, 2015
    Report Date
    June 1, 2015
    Manufacturer
    B.BRAUN MELSUNGEN AG
    Product Code
    MEB
    PMA / PMN Number
    K081905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO SAMPLE WAS AVAILABLE FOR EVALUATION. WITHOUT THE ACTUAL SAMPLE, USER, AND / OR FACILITY CONTACT INFORMATION, A THOROUGH INVESTIGATION COULD NOT BE PERFORMED AND NO SPECIFIC CONCLUSION CAN BE DRAWN AS TO THE CAUSE OF THE REPORTED EVENT. IF A SAMPLE AND/OR ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. . NO USER CONTACT INFORMATION.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY THROUGH MEDWATCH:PER MEDWATCH REPORT #(B)(4), "VOLUN (B)(6)-2015: ACCUFLOW (B)(4) LOT #100925 USED TO ADMINISTER A DOSE OF 5-FLUOROURACIL OVER 23 HOURS. THE DEVICE IS AN ELASTOMERIC INFUSION DEVICE WITH 4MG/HR RATE AND 120ML VOLUME. THE DEVICE WAS PLACED ON THE PT. AT 1300 (B)(6) 2015 TO ADMINISTER THE DOSE OVER THE 23 HOURS. THE PT. CALLED THE INFUSION CENTER ON (B)(6) 2015 STATING THAT THE DEVICE WAS EMPTY AT 0134 ON (B)(6) 2015. THE INFUSION SHOULD HAVE BEEN RUNNING UNTIL APPROXIMATELY 1200 ON (B)(6) 2015. THE ENTIRE 23 HOUR INFUSION WAS INFUSED OVER APPROX 12 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385849 ACCUFLO ELASTOMERIC INFUSION PUMP MEB B.BRAUN MELSUNGEN AG CT-0040-120C 100925

    Patients

    Seq Age Sex Outcome Treatment
    1