BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2240003 · Received September 8, 2011

    Report

    Report Number
    6000001-2011-23399
    Event Type
    Malfunction
    Date Received
    September 8, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 19, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K003225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE IS NOT AVAILABLE FOR EVALUATION; THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. A BATCH REVIEW CANNOT BE PERFORMED SINCE THERE WAS NO LOT NUMBER PROVIDED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER PRODUCT SURVEILLANCE OF AN EXTENSION SET IN WHICH AN AIR IN LINE ALARM OCCURRED. THIS HAPPENED WHEN THIS SET WAS CONNECTED TO A PLUM SET THAT HAS PITTOSIN MEDICATION BEING PUMPED THROUGH A PLUM PUMP (WHEN THIS SET IS NOT USED, THERE IS NO ALARM). THE ALARM OCCURRED WHEN THE RATE WAS INCREASED FROM THE LOWEST RATE SETTING. THIS CONDITION OCCURRED DURING AN INFUSION. THERE WERE NO REPORTS OF PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 PLUM SET, PLUM PUMP| PITTOSIN MEDICATION