BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2870820 · Received December 12, 2012

    Report

    Report Number
    1416980-2012-07170
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    October 31, 2012
    Report Date
    November 30, 2012
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPB
    PMA / PMN Number
    K113227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).EVALUATION SUMMARY: THE SAMPLE WAS RECEIVED FOR EVALUATION. THE SAMPLE PASSED VISUAL INSPECTION, PRESSURE TESTING, AND ALL FUNCTIONAL TESTS. THE CUSTOMER REPORTED CONDITION WAS NOT CONFIRMED AND A CAUSE COULD NOT BE IDENTIFIED. (B)(4). A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER CALLED BAXTER CORPORATE PRODUCT SURVEILLANCE TO REPORT A 60" MICRO VOLUME EXTENSION SET IN WHICH A LEAK OCCURRED. ACCORDING TO THE REPORT, A HOME PATIENT WAS GOING THROUGH REMODULIN PULMONARY HYPERTENSION THERAPY AND WHEN THE DRUG WAS INJECTED INTO THE SET WITH A "CHRONO FIVE" SYRINGE, A LEAK WAS OBSEREVED. IT IS UNKNOWN IF THE LEAK OCCURRED BETWEEN THE EXTENSION SET AND THE SYRINGE OR WITHIN THE EXTENSION SET ITSELF. THE EVENT OCCURRED DURING PATIENT USE. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS FILTER, INFUSION LINE FPB BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1 "CHRONO FIVE" SYRINGE