BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODEL 3000 30ML MED FLOW PUMP

    MDR report key: 1012950 · Received March 13, 2008

    Report

    Report Number
    1226348-2008-00053
    Event Type
    Injury
    Date Received
    March 13, 2008
    Date of Event
    March 13, 2006
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    LKK
    PMA / PMN Number
    P890055
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 PROPER INVESTIGATION. SINCE A SERIAL NUMBER HAS BEEN PROVIDED, A REVIEW OF THE MANUFACTURING RECORDS HAVE BEEN REVIEWED 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.

    Description of Event or Problem · 1

    AFFILIATE EXPLAINED THAT THE DOCTOR DESCRIBED THAT THE RECEIVED THE PUMP IN A DRY CONDITION. THE MECHANICAL DRIVE SYSTEM COULD PROVE THAT THE PUMP WAS LEAK TIGHT. THEY FILLED THE PUMP WITH 30 ML WATER DURING THE REFILL PROCEDURE AIR ESCAPED. THE PUMP DEVELOPED ONLY FOR A SHORT TIME (0.08G OVER 24 HOURS). THE DR ASSUMED THAT THE FILTER TO THE REDUCE CAPILLARY WAS BLOCKED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention