BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2241769 · Received September 9, 2011

    Report

    Report Number
    6000001-2011-23619
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 16, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS UNKNOWN IF THE SAMPLE IS AVAILABLE FOR EVALUATION. HOWEVER, IF THE CUSTOMER DECIDES TO SEND IN THE SAMPLE, A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION HAS BEEN PERFORMED. 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 A CLEAR LINK SET IN WHICH WHEN IT IS CONNECTED TO THE HOSPIRA PLUM PRIMARY SET CASSETTE PORT, THE SET GETS STUCK TO THE CASSETTE DURING AN INFUSION. THE SECONDARY SET IS CONNECTED DIRECTLY TO THE PORT AND DOES NOT HAVE A PRECONNECTED CLAVE PORT. SINCE IT IS TOO DIFFICULT TO REMOVE THE SET, THE PRIMARY SET IS THROWN AWAY AND IT IS NOT EFFICIENT FOR THE NURSES. THERE WERE NO PATIENT INJURIES REPORTED. THEY HAVE ASKED FOR A FOLLOW UP BY THE SALES THERAPY REPRESENTATIVE TO DETERMINE IF THE SOLUTION OF NOT TIGHTENING SO HARD SHOWS IMPROVEMENT, OR IF ADDING A MAXPLUS CLEAR INJECTION PORT TO THE OPEN HUB ALLOWS FOR IMPROVEMENT AS WELL. 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, CASSETTE PORT