BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT2® IV GRAVITY FLOW CONTROLLER EXTENSION SET

    MDR report key: 2065771 · Received April 21, 2011

    Report

    Report Number
    3007305485-2011-00039
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Report Date
    April 27, 2011
    Manufacturer
    CONMED CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K905498A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORT FOR THIS INCIDENT WAS INCORRECTLY REPORTED WITH AN FDA PRODUCT CODE OF LHI: SET, IV FLUID, TRANSFER. THE CORRECT FDA PRODUCT CODE FOR THIS DEVICE IS FPA: SET, ADMINISTRATION, INTRAVASCULAR.THE INITIAL REPORT FOR THIS INCIDENT WAS INCORRECTLY REPORTED WITH THE WRONG 510(K) NUMBER. THE CORRECT 510(K) NUMBER, K905498A.

    Additional Manufacturer Narrative · 1

    THIS INCIDENT WAS ORIGINALLY EVALUATED AS A NON-MDR REPORTABLE INCIDENT. REVIEW OF THE DFMEA, DESIGN FAILURE MODE AND EFFECTS ANALYSIS, DOCUMENT FOR S2 IV CONTROLLERS STATES, " A POTENTIAL FAILURE MODE OF FLUID DELIVERY IN UNCONTROLLED AMOUNTS, RESULTING IN IMPROPER DOSAGE, FOR DIAL OFFERS NO VARIABILITY." THIS IS ANALYZED AS A SEVERITY OF 6, PRODUCT PERFORMANCE SEVERELY AFFECTED. USER DISRUPTION (WITH ALTERNATIVE AVAILABLE). DUE TO THE LOW SEVERITY OF RISK, AND, NO PATIENT INJURY REPORTED, THIS WAS NOT ORIGINALLY EVALUATED AS AN MDR REPORTABLE INCIDENT. CONMED EXPERIENCED AN INCREASE IN THE COMPLAINTS REGARDING STAT2 IV GRAVITY FLOW CONTROLLERS SPECIFICALLY FOR INACCURATE FLOW RATES. THIS INCREASE IN COMPLAINTS RESULTED IN AN INVESTIGATION BEING OPENED TO DETERMINE THE SCOPE AND SOURCE OF THE STAT2 IV GRAVITY FLOW CONTROLLER DEFECT. THE STAT2 INVESTIGATION PROMPTED THAT A HEALTH HAZARD EVALUATION, HHE, BE CONDUCTED IN REGARDS TO 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 CHANGING THE RISK ASSOCIATED WITH THIS INCIDENT. THE CHANGE IN RISK ASSESSMENT HAS DETERMINED THIS TO BE A REPORTABLE INCIDENT WITH A NEW AWARENESS DATE OF 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, "THE CONTROLLER IS NOT PROPERLY REGULATING THE FLOW." THERE WAS NO REPORT OF ANY PATIENT INJURY ASSOCIATED WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAT2® IV GRAVITY FLOW CONTROLLER EXTENSION SET STAT 2 EXTENSION SET FPA CONMED CORPORATION 1010274

    Patients

    Seq Age Sex Outcome Treatment
    1