BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDSTREAM PROGRAMMABLE INFUSION PUMP 20ML

    MDR report key: 2243749 · Received September 12, 2011

    Report

    Report Number
    1226348-2011-00343
    Event Type
    Injury
    Date Received
    September 12, 2011
    Date of Event
    August 8, 2011
    Manufacturer
    CODMAN AND SHURTLEFF - RAYNHAM
    Product Code
    LKK
    PMA / PMN Number
    P890055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE ROOT CAUSE OF THE DISCREPANCIES BETWEEN THE FLOW RATE PROGRAMMED BY THE SURGEON AND THE VALUES REPORTED BY THE FILL LEVEL SENSOR WAS NOT DETERMINED. NO DEFECT WAS FOUND DURING INVESTIGATION, IT HAS NOT BEEN POSSIBLE TO REPRODUCE THE LEAKAGE SUSPECTED BY THE CUSTOMER IN THE LABORATORY SETTING. BASED ON THE RESULT OF THE INVESTIGATION NO CORRECTIVE ACTION WAS INITIATED. CODMAN WILL MONITOR TRENDS FOR SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT THE DEVICE IS EMPTYING FASTER THAN IT IS SCHEDULED FOR. THERE IS NO SIGN OF PATIENT OVERDOSE. AS A RESULT THE DEVICE WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDSTREAM PROGRAMMABLE INFUSION PUMP 20ML PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK CODMAN AND SHURTLEFF - RAYNHAM CMCB8N

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention