BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODEL 3000 30ML LOW FLOW PUMP

    MDR report key: 2760660 · Received September 26, 2012

    Report

    Report Number
    1226348-2012-00474
    Event Type
    Injury
    Date Received
    September 26, 2012
    Manufacturer
    CODMAN AND SHURTLEFF - RAYNHAM
    Product Code
    LKK
    PMA / PMN Number
    P890055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THIS COMPLAINT COULD NOT BE CONFIRMED. THE DEVICE WAS VISUALLY AND FUNCTIONALLY TESTED AND WAS FOUND TO WORK IN ACCORDANCE WITH THE MANUFACTURING SPECIFICATIONS. THE PROBLEM REPORTED BY THE CUSTOMER COULD NOT BE DUPLICATED IN THE LABORATORY SETTING. A REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THAT THIS DEVICE CONFORMED TO THE REQUIRED SPECIFICATIONS PRIOR TO DISTRIBUTIONS. BASED ON THE RESULTS OF THIS INVESTIGATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

    Description of Event or Problem · 1

    PATIENT CONTACTED US IDENTIFYING THAT SHE SUFFERED WHAT APPEARED TO BE AN OVERDOSE ON (B)(6), 2011. THE OVERDOSE RESULTED IN HOSPITALIZATION AND ADMINSTRATION OF NARCAN. THERAPY CHANGED TO ORAL MEDS. PUMP CONTAINED MORPHINE AND CLONADINE (AND POSSIBLE ANOTHER DRUG - PATIENT WAS UNSURE). PUMP WAS EMPTIED AT THE TIME OF SYMPTOMS OF OVERDOSE AND THE VOLUME WAS FOUND TO BE CORRECT FOR THE FLOW RATE/REFILL SCHEDULE BY THE PAIN MANAGEMENT DOCTO. THE PUMP REMAINED IMPLANTED UNTIL (B)(6), 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODEL 3000 30ML LOW FLOW PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK CODMAN AND SHURTLEFF - RAYNHAM 13420

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention