BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP II LT 100-200-S

    MDR report key: 2945201 · Received January 31, 2013

    Report

    Report Number
    3009089744-2013-00008
    Event Type
    Malfunction
    Date Received
    January 31, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 31, 2013
    Manufacturer
    B. BRAUN MEDICAL PRODUCTION LTD.
    Product Code
    MEB
    PMA / PMN Number
    K081905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN (B)(4). THE DEVICE IS CURRENTLY ON SHIPPING FROM THE CUSTOMER 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 INFO BY BBM SALES ORGANIZATION IN (B)(6)): THE PUMP WAS FILLED WITH SODIUM CHLORIDE. INSIDE THE TUBE SEVERAL AIR BUBBLES WERE DETECTED WHICH COULD NOT BE REMOVED. MOREOVER THE PUMP DID NOT START RUNNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43172 EASYPUMP II LT 100-200-S ELASTOMERIC INFUSION PUMP MEB B. BRAUN MEDICAL PRODUCTION LTD. NA 2D2828ES11

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other