BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3910830 · Received July 2, 2014

    Report

    Report Number
    1416980-2014-21360
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 11, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FPA
    PMA / PMN Number
    K123868
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: BAXTER RECEIVED ONE SAMPLE FOR EVALUATION. VISUAL AND MICROSCOPIC INSPECTIONS WERE PERFORMED. THE TUBING CONNECTED TO THE DRIP CHAMBER WAS FOUND TO BE CRIMPED INSIDE THE CONNECTION TO THE DRIP CHAMBER. A FUNCTIONAL FLOW TEST WAS PERFORMED BY ATTACHING THE SET TO AN IN-HOUSE SOLUTION BAG; THE SOLUTION FLOWED WITH NO PROBLEMS. A LEAK WAS OBSERVED WHERE THE TUBING WAS CRIMPED. A LEAK TEST WAS PERFORMED AND A LEAK WAS VERIFIED AT THE CONNECTION OF THE TUBING TO THE DRIP CHAMBER. THE CAUSE WAS DETERMINED TO BE INEFFECTIVENESS AND INCONSISTENCY OF SENSOR DETECTION AND ALSO RE-APPLYING THE SOLVENT AFTER MACHINE STOPPAGES THAT MIGHT LEAD INSUFFICIENT SOLVENT ON TUBING. TO CORRECT THE ISSUE THE SENSOR POSITION WAS OPTIMIZED AND INSPECTED FOR PROPER FUNCTION AT ALL SOLVENT APPLICATION STATIONS. IN ADDITION AWARENESS TRAINING WAS PROVIDED FOR THE OPERATORS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS IN PROGRESS. UPON COMPLETION OF THE INVESTIGATION, OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTERLINK SOLUTION SET LEAKED FROM ¿RIGHT ABOVE THE LUER¿ DURING PRIMING WITH 0.9% SODIUM CHLORIDE SOLUTION. THE REPORTER STATED THAT THE LEAK WAS ¿PRETTY SIGNIFICANT,¿ AND LED TO THE SOLUTION LEAKING ONTO HER SKIN. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386945 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 0.9% SODIUM CHLORIDE SOLUTION