BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT2® PUMPETTE IV GRAVITY FLOW COMPENSATING CONTROLLER-20 DROPS/ML

    MDR report key: 2081944 · Received May 9, 2011

    Report

    Report Number
    3007305485-2011-00049
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Report Date
    May 9, 2011
    Manufacturer
    CONMED CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K905498A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONMED EXPERIENCED AN INCREASE IN THE COMPLAINTS REGARDING STAT2 PUMPETTE IV GRAVITY FLOW COMPENSATING CONTROLLERS SPECIFICALLY FOR LEAKING AND INACCURATE FLOW RATES. THIS INCREASE IN COMPLAINTS RESULTED IN AN INVESTIGATION BEING OPENED TO DETERMINE THE SCOPE AND SOURCE OF THE STAT2 PUMPETTE IV GRAVITY FLOW COMPENSATING CONTROLLER DEFECT. THE STAT2 INVESTIGATION PROMPTED THAT A HEALTH HAZARD EVALUATION, HHE, BE CONDUCTED IN REGARDS TO LEAKING AND INACCURATE FLOW RATES. BASED ON THE COMPLETED HHE, CONMED DETERMINED THAT, IF THE DEVICE IS UNABLE TO REGULATE FLOW AS SET AND CONFIRMED BY THE ATTENDING MEDICAL STAFF, AND, THE DELIVERY OF ESSENTIAL MEDICATIONS OR TREATMENT IS DEPENDENT ON THE DEVICE'S FUNCTION, THIS MAY RESULT IN POSSIBLE INJURY TO THE PATIENT. THIS HHE WAS APPROVED 01 APRIL 2011. THE FDA HAS BEEN NOTIFIED OF A FIELD REMEDIAL ACTION. CONMED IS CONSIDERING THIS INDIVIDUAL COMPLAINT CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED, " LEAKING AROUND THE DIAL." NO PATIENT INJURY WAS REPORTED ASSOCIATED WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAT2® PUMPETTE IV GRAVITY FLOW COMPENSATING CONTROLLER-20 DROPS/ML STAT2 IV CONTROLLER-20 DROP FPA CONMED CORPORATION 1012024

    Patients

    Seq Age Sex Outcome Treatment
    1