BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODEL 3000-30ML LOW FLOW PUMP

    MDR report key: 3023562 · Received March 27, 2013

    Report

    Report Number
    1226348-2013-14098
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    August 14, 2008
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    LKK
    PMA / PMN Number
    PP890055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    IT HAS BEEN COMMUNICATED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. SINCE A LOT NUMBER HAS BEEN PROVIDED A REVIEW OF THE MANUFACTURING RECORDS HAVE BEEN CONDUCTED AND THEY REVEALED THAT THE DEVICE CONFORMED TO ALL MANUFACTURING AND QUALITY TESTING/INSPECTION SPECIFICATIONS PRIOR TO BEING RELEASED TO STOCK. IF AT SOME POINT THE DEVICE IS RETURNED FOR EVALUATION THIS COMPLAINT WILL BE RE-OPENED AND INVESTIGATED. BASED ON THIS EVALUATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT, "THIS PUMP GAVE ME AN OVERDOSE, THIS PUMP ALMOST KILLED ME." SURGEON'S OFFICE WAS CONTACTED AND IT WAS EXPLAINED THAT THE PUMP APPEARED TO BE FLOWING SLOWLY. AFTER A REFILL PROCEDURE, THE PATIENT HAD SYMPTOMS OF AN OVERDOSE. THEREFORE THE PUMP WAS EXPLANTED AND REPLACED WITH A COMPETITOR'S PUMP. THE PUMP WAS DISCARDED BY THE CLINICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126619 MODEL 3000-30ML LOW FLOW PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK CODMAN & SHURTLEFF, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention