BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK 1.2 MICRON EXTENSIONSET

    MDR report key: 2012464 · Received March 9, 2011

    Report

    Report Number
    6000001-2011-01745
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    December 13, 2010
    Report Date
    February 14, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K952074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER RETURNED ONE USED SAMPLE ATTACHED TO A 2C8541 CLEARLINK CONTINU-FLO SOLUTION SET. THE SETUP HAD BEEN FULLY PRIMED. THE COMPLAINT SAMPLE WAS RE-PRIMED PER LABEL COPY BY SPIKING THE SETUP INTO A 1000ML SOLUTION BAG CONTAINING STERILE WATER. THIS SHOWED LEAKAGE AT BOTH VENTS OF THE FILTER HOUSING. THE SAMPLE WAS THEN REMOVED FROM THE 2C8541 CONTINU-FLO SET AND PRESSURE TESTED. THIS AGAIN IDENTIFIED THE LEAK AT BOTH VENTS AT A PRESSURE < 5 PSI. NO LEAKAGE WAS DETECTED FROM THE HOUSING OR HOUSING SEALS. VISUAL INSPECTION DID NOT FIND ANY DEFECTS OR ISSUES THAT COULD IDENTIFY THE CAUSE OF THE CONDITION. THE COMPLAINT WILL BE CONFIRMED. THE SAMPLE HAS BEEN SENT TO THE SUPPLIER FOR FURTHER ANALYSIS. A BATCH REVIEW WAS PERFORMED ON THE LOT THAT THE CUSTOMER GUESSED THE PRODUCT WAS TAKEN FROM, AND NO DEVIATIONS WERE FOUND. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE BUT HAS NOT BEEN RECEIVED FOR EVALUATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE OR THE SAMPLE IS RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CORPORATE PRODUCT SURVEILLANCE THAT THE SET FILTER BEGAN LEAKING FROM THE HOLE IN EACH OF THE TWO AIR VENTS ON THE WHITE SIDE OF THE FILTER IN THE CLEARLINK 1.2 MICRON EXTENSION SET. THE SET WAS RUNNING TPN, WHICH ONLY RUNS FOR 24 HRS, AND THE LEAK WAS NOTED PRIOR TO 24 HOURS. THE CONDITION OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEARLINK 1.2 MICRON EXTENSIONSET SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE R10D24042

    Patients

    Seq Age Sex Outcome Treatment
    1