BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3091913 · Received May 3, 2013

    Report

    Report Number
    1416980-2013-11200
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Report Date
    April 11, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EXACT DATE OF OCCURRENCE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE OCCURRENCE IS KNOWN TO HAVE HAPPENED APPROXIMATELY ONE WEEK PRIOR TO THE EVENT BEING REPORTED TO BAXTER. A BATCH REVIEW CANNOT BE PERFORMED SINCE THERE WAS NO LOT NUMBER PROVIDED. THE SAMPLE WAS NOT RECEIVED FOR EVALUATION. THE CUSTOMER REPORTED CONDITION COULD NOT BE CONFIRMED AND THE ROOT CAUSE WAS NOT IDENTIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CLEARLINK CONTINU-FLO SOLUTION SET SEPARATED. DURING THE ADMINISTRATION OF A BOLUS DOSE OF SALINE, THE CLEARLINK Y-SITE CLOSEST TO THE PATIENT SEPARATED FROM THE TUBING. 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
    194189 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 NORMAL SALINE