BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP II ST 100-0, 5-S

    MDR report key: 3050610 · Received March 13, 2013

    Report

    Report Number
    3009089744-2013-00052
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 13, 2013
    Report Date
    March 13, 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

    (B)(4). THE DEVICE IS CURRENTLY ON SHIPPING FROM (B)(6) TO B. BRAUN (B)(4) FOR INVESTIGATION. A FOLLOW-UP 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 INFORMATION BY BBM SALES ORGANIZATION IN (B)(6)): SLOW FLOW. INFUSION TOOK 1 HOUR INSTEAD OF 30 MINUTES. DRUG: CETOFAXIME 4G.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106251 EASYPUMP II ST 100-0, 5-S ELASTOMERIC INFUSION PUMP MEB B. BRAUN MEDICAL PRODUCTION LTD. NA 2E2928EU11

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other