BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP II LT 270-27-S

    MDR report key: 2961232 · Received February 8, 2013

    Report

    Report Number
    3009089744-2013-00015
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Report Date
    February 8, 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)(4) 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)(4)): STOP INFUSION. PATIENT FOLLOWED BY THE (B)(6) HOSPITAL FOR CYSTIC FIBROSIS. THE FIRST INFUSOR DID NOT DELIVER QUICKLY. THE SECOND DID NOT DELIVER PROPERLY EITHER. THE THIRD DELIVERS PROPERLY YESTERDAY. THE PATIENT IS REPORTED BY A NURSE, SHE IS THE SAME WHO MADE THE THREE FILLINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54925 EASYPUMP II LT 270-27-S ELASTOMERIC INFUSION PUMP MEB B. BRAUN MEDICAL PRODUCTION LTD. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other