BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK SYSTEM NON-DEHPCONTINU-FLO SOLN SET

    MDR report key: 2060382 · Received April 15, 2011

    Report

    Report Number
    6000001-2011-02915
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 31, 2011
    Report Date
    April 1, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE IS AVAILABLE FOR EVALUATION; HOWEVER, THE SAMPLE HAS NOT YET BEEN RECEIVED. ONCE THE SAMPLE IS RECEIVED AND EVALUATED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). AN ACTUAL SAMPLE WAS SUBMITTED FOR EVALUATION SINCE THE CUSTOMER STATED THAT THE Y-SITE PROXIMAL TO THE MALE LUER HAD A NO FLOW. A VISUAL EXAMINATION OF THE SAMPLE DID NOT REVEAL ANY ABNORMALITIES. PRIOR TO TESTING THE Y SITE FOR FLOW BOTH Y SITES WERE VISUALLY INSPECTED FOR RE-KNIT. THE SAMPLE WAS THEN CHECKED FOR FLOW BY SPIKING THE SET INTO A 1000ML SOLUTION BAG CONTAINING STERILE WATER AND RE-PRIMING PER LABEL COPY. A 2C7461 IN-HOUSE SECONDARY SET ALSO SPIKED INTO A 1000ML SOLUTION BAG WAS THEN ATTACHED TO EACH Y SITE. BOTH Y SITES WERE THEN CHECKED FOR FLOW. THERE WAS NO RE-KNIT NOTED IN EITHER Y SITE GLAND. THE SET PRIMED NORMALLY. BOTH Y SITES FLOWED NORMALLY. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE ROOT CAUSE OF THIS CONDITION WAS NOT IDENTIFIED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SAMPLE REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER PRODUCT SURVEILLANCE OF ONE (1) CLEARLINK SET IN WHICH A NO-FLOW WAS DETECTED AT THE Y-SITE PROXIMAL TO THE MALE LUER END OF THE SET. THIS REPORTED CONDITION OCCURRED DURING SETUP WHILE UTILIZING SALINE. NO PATIENT INVOLVEMENT, INJURY OR ADVERSE EVENT IS REPORTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEARLINK SYSTEM NON-DEHPCONTINU-FLO SOLN SET SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE R10J11138

    Patients

    Seq Age Sex Outcome Treatment
    1 SALINE