BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3000482 · Received March 12, 2013

    Report

    Report Number
    1416980-2013-05944
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 22, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: VISUAL INSPECTION IDENTIFIED A CRACK IN THE FRAME OF THE ROLLER CLAMP. THE CAUSE OF THE CRACK WAS UNDETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW CANNOT BE PERFORMED SINCE THERE WAS NO LOT NUMBER PROVIDED. INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. UPON COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SIMULATION INFUSION AT A NURSING SCHOOL, A CLEAR LINK SECONDARY MEDICATION SETS ON/OFF CLAMP CRACKED. THE SET WAS PRIMED AND THEN ATTACHED TO AN UNKNOWN PRIMARY SET THAT WAS HOOKED UP TO A SIMULATION PATIENT. AFTER THE INFUSION STARTED, THE STUDENT ATTEMPTED TO CLOSE THE CLAMP. AT THIS TIME THE CLAMP CRACKED ON THE BOTTOM AND UP THE SIDES RESULTING IN A SOLUTION FREE-FLOWING FROM THE SECONDARY BAG. THERE WAS NO PATIENT INVOLVEMENT. THEREFORE, 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
    103761 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1