BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3873401 · Received June 13, 2014

    Report

    Report Number
    1416980-2014-19025
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 20, 2014
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE PERFORMED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CLEARLINK OF A CLEARLINK DUO-VENT CONTINU-FLO SET WOULD NOT ALLOW SOLUTION TO FLOW THROUGH IT. THIS OCCURRED DURING PATIENT INFUSION, WHILE A NON-BAXTER ADAPTER WAS CONNECTED TO THE Y-SITE CLOSEST TO THE PATIENT. THE REPORTER STATED THAT THERE WERE NO ISSUES WITH THE OTHER TWO Y-SITES AND THEY WERE OCCASIONALLY ABLE TO OBTAIN FLOW BY CHANGING THE ADAPTER AND FLUSHING THE SETUP WITH NORMAL SALINE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349701 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE R14A21107

    Patients

    Seq Age Sex Outcome Treatment
    1 PD PHASEAL ADAPTER