BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3033732 · Received April 3, 2013

    Report

    Report Number
    1416980-2013-08301
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 11, 2013
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K120443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION, FUNCTIONAL TESTS AND PRESSURE TESTS WERE PERFORMED. THE SAMPLE WAS FOUND TO BE WITHIN SPECIFICATION LIMITS AND FUNCTIONED NORMALLY. THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW CANNOT BE PERFORMED SINCE THERE WAS NO LOT NUMBER PROVIDED. THE DEVICE WAS RETURNED TO BAXTER AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SEPTUM OF A ONE-LINK NEEDLE FREE INTRAVENOUS CONNECTOR COLLAPSED. A CADD PRIZM PUMP WAS PROGRAMMED TO INFUSE VANCOMYCIN AT A RATE OF 187 ML/HR EVERY 12 HOURS WITH A KEEP VEIN OPEN RATE OF 1 ML/HR IN BETWEEN THE INTERMITTENT INFUSIONS. THE INFUSIONS WERE GIVEN INTERMITTENTLY OVER AN UNKNOWN AMOUNT OR TIME. THE MALFUNCTION WAS IDENTIFIED DURING THE SCHEDULED CHANGE OF THE ONE-LINK CONNECTOR. THERE WAS PATIENT INVOLVEMENT; HOWEVER THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT IN ASSOCIATION WITH THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136394 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1 VANCOMYCIN, CADD PRIZM PUMP, UNKNOWN TUBING