BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDSTREAM PROGRAMMABLE INFUSION PUMP 20ML

    MDR report key: 3772191 · Received April 25, 2014

    Report

    Report Number
    1226348-2014-11418
    Event Type
    Injury
    Date Received
    April 25, 2014
    Date of Event
    June 20, 2012
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AFTER A RMI, THE PUMP WAS CHECKED AND THE STAFF FOUND OUT THAT THE PUMP GAVE THE FOLLOWING ERROR: HARDWARE ERROR 11 (PLEASE NOTE OUR SALES REP WAS PRESENT DURING THIS CHECK) THE DAY AFTER THIS RMI, PATIENT WENT TO THE HOSPITAL WHERE OUR PRODUCT MANAGER ((B)(6)) WITH SUPPORT OF (B)(6) RESTARTED THE PUMP. NO ADVERSE REACTION ON PATIENT. (B)(4) ADDITIONAL INFORMATION EXPLAINED THAT THE DEVICE WAS DISTRIBUTED WITH THE OLD IFU. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252245 MEDSTREAM PROGRAMMABLE INFUSION PUMP 20ML PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK NLBHC8

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention