BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP II ST 400-2-S

    MDR report key: 2904646 · Received January 4, 2013

    Report

    Report Number
    3009089744-2012-00018
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    December 10, 2012
    Report Date
    January 4, 2013
    Manufacturer
    B. BRAUN MEDICAL PRODUCTION LTD.
    Product Code
    MEB
    PMA / PMN Number
    K081905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS (B)(4). THE DEVICE IS CURRENTLY ON SHIPPING FROM (B)(6) FOR INVESTIGATION. A F/U REPORT WILL BE PROVIDED AFTER THE INSPECTION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFO BY (B)(4) SALES ORGANIZATION IN (B)(4)): DRUG: TIENAM 2G - 400 ML. THE 200 ML INFUSED THE FIRST 2 HRS - AFTER 5 HRS, 50 ML REMAINED IN THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4191 EASYPUMP II ST 400-2-S ELASTOMERIC INFUSION PUMP MEB B. BRAUN MEDICAL PRODUCTION LTD. NA 2D0728EA21

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other