BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CL CONTINU-FLO SOLN SET W/CONTROL-A-FLO

    MDR report key: 1932628 · Received December 19, 2010

    Report

    Report Number
    6000001-2010-06018
    Event Type
    Malfunction
    Date Received
    December 19, 2010
    Date of Event
    June 24, 2010
    Report Date
    July 13, 2010
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K940867
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL UNIT WAS RECEIVED FOR EVALUATION PURPOSES. UNIT WAS VISUALLY INSPECTED. EVALUATION WAS PERFORMED PER SPECIFICATIONS. DURING VISUAL INSPECTION UNIT DOES NOT PRESENT VISUAL DEFECT. UNIT RESULTS SATISFACTORY TO FUNCTIONAL TEST. THE REPORTED CONDITION WAS NOT CONFIRMED. A BATCH REVIEW WAS PERFORMED ON THE REPORTED LOT AND NO DEVIATIONS WERE FOUND. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER CORPORATE PRODUCT SURVEILLANCE OF A NO FLOW THAT OCCURRED ON A CLEARLINK CONTINU-FLO SOLUTION SET. THE PATIENT'S TREATMENT WITH METHYLPREDNISOLONE WAS DELAYED FOR AN UNKNOWN PERIOD OF TIME. THIS INFUSION WAS BEING DONE VIA GRAVITY AND THE PATIENT HAS BEEN TRAINED ON HOW TO PRIME THE TUBING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CL CONTINU-FLO SOLN SET W/CONTROL-A-FLO SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO UR10D14167

    Patients

    Seq Age Sex Outcome Treatment
    1 METHYLPREDNISOLONE