BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3981202 · Received August 5, 2014

    Report

    Report Number
    1416980-2014-25366
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    May 30, 2014
    Report Date
    July 11, 2014
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K132734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A ONE-LINK NEEDLE-FREE IV CONNECTOR WAS INVOLVED IN A NO FLOW INCIDENT. THIS OCCURRED DURING PATIENT INFUSION OF TOTAL PARENTERAL NUTRITION (TPN) SOLUTION USING AN UNKNOWN IV PUMP, AN UNKNOWN SET, THE IV CONNECTOR, AND A CENTRAL VENOUS CATHETER (CVC). THE PUMP ALARMED FOR A DOWNSTREAM OCCLUSION. THE NURSE THEN ATTEMPTED TO FLUSH THE CVC PORT BUT WAS UNABLE TO. THE ONE-LINK IV CONNECTOR WAS THEN REMOVED AND NO ISSUES WERE ENCOUNTERED IN FLUSHING THE UNKNOWN SET. THE ORIGINAL SETUP WAS THEN PUT BACK TOGETHER WITHOUT THE IV CONNECTOR AND PUMP DID NOT ALARM AGAIN. 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
    458094 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN SET| UNKNOWN IV PUMP| TOTAL PARENTERAL NUTRITION (TPN) SOLUTION| CENTRAL VENOUS CATHETER