BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2973030 · Received February 21, 2013

    Report

    Report Number
    1416980-2013-04408
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 13, 2013
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K120443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT RETURNED FOR EVALUATION. THE CUSTOMER'S REPORTED CONDITION WAS NOT CONFIRMED; THE ROOT CAUSE WAS NOT IDENTIFIED. THE REPORTER DID NOT KNOW WHAT WAS BEING INFUSED; IT WAS EITHER NORMAL SALINE OR LACTATED RINGERS. A BATCH REVIEW CANNOT BE PERFORMED SINCE THERE WAS NO LOT NUMBER PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNKNOWN NUMBER OF ONE-LINK CONNECTORS WERE OBSERVED TO EXPERIENCE NO FLOWS. THE FACILITY INFORMED THAT THE ONE-LINK LUER, WHEN CONNECTED TO THE UNKNOWN PRIMARY SET, CAUSED THE PUMP TO ALARM "OCCLUSION." THE NURSE ATTEMPTED TO DISCONNECT AND RECONNECT THE PRIMARY SET FROM THE ONE-LINK THREE TIMES WITH THE SAME RESULT. THE NURSE THEN DISCONNECTED AGAIN, REMOVED THE ONE-LINK LUER AND CONNECTED THE PRIMARY SET DIRECTLY TO THE HUB. THIS MALFUNCTION WAS REPORTED TO HAVE OCCURRED DURING INFUSION ON A PATIENT. 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
    75976 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1 SIGMA SPECTRUM PUMP| UNKNOWN PRIMARY SET