BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDSTREAM PUMP 40ML

    MDR report key: 3953434 · Received July 23, 2014

    Report

    Report Number
    1226348-2014-11841
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    July 11, 2014
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    LKK
    PMA / PMN Number
    PP890055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP REMAINS IMPLANTED AT THIS TIME, THEREFORE; EVALUATION OF THE PUMP IS NOT POSSIBLE AT THIS TIME. THE SALES REP WAS NOTIFIED AND ASKED TO PROVIDE DETAILED TRANSACTION LOGS/CLINICAL FLOW DATA TO FURTHER VERIFY FLOW CONDITIONS. HOWEVER, THE REQUIRED LOGS WERE NOT PROVIDED, THE FLOW DATA/SCREEN SHOTS PROVIDED WERE NO SUFFICIENT TO ACCURATELY CALCULATE/VERIFY THE "OVERDOSE" CONDITION REPORTED. A DHR REVIEW WAS PERFORMED FOR THE MEDSTREAM PUMP 91-4201US SN: (B)(4) (LOT#CNMCR4), AND NO DISCREPANCIES WERE OBSERVED DURING THE MANUFACTURING PROCESS. THE LOT WAS RELEASED ON NOVEMBER 21ST 2012. AT THIS TIME THIS COMPLAINT IS CONSIDERED TO BE CLOSED. SHOULD THE PUMP BE EXPLANTED AND/OR THE TRANSACTION LOGS BE PROVIDED, THIS COMPLAINT WILL BE REOPENED AND THE PUMP AND/OR TRANSACTION DATA WILL BE EVALUATED. WE WILL CONTINUE TO MONITOR FOR THIS OR SIMILAR COMPLAINTS FOR THIS PRODUCT CODE. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED. COMPLAINT SAMPLE NOT RETURNED.

    Description of Event or Problem · 1

    DUE TO THE LENGTH OF EVENT DESCRIPTION; THE DOCUMENT RECEIVED WAS ATTACHED TO THIS MEDWATCH. PLEASE NOTE:THE PRODUCT CODE WAS MODIFIED FROM 914282US TO 914201US BASED ON THE SERIAL NUMBER PROVIDED; PUMP IS STILL IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430187 MEDSTREAM PUMP 40ML PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK CODMAN & SHURTLEFF CNMCR4

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention