BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLINK CONTINU-FLO, 3 INJECTION SITES, LUER LOCK, 105"

    MDR report key: 1941496 · Received December 29, 2010

    Report

    Report Number
    6000001-2010-06346
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    May 19, 2010
    Report Date
    May 19, 2010
    Manufacturer
    BAXTER HEALTHCARE - SHERBROOKE
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER SENT IN 2 ACTUAL AND 45 COMPANION INTERLINK CONTINU-FLOW SAMPLES THAT WERE EVALUATED FOR NO FLOW. A VISUAL INSPECTION AND FUNCTIONAL TESTING WAS PERFORMED AND THE REPORTED CONDITION WAS CONFIRMED ON SEVERAL OF THE SETS. THE PRIMING DIFFICULTY ISSUE IS RELATED TO A HIGH CRACKING PRESSURE OF THE NYPRO CHECK VALVE. AS A RESULT, A CAPA HAS BEEN INITIATED TO ADDRESS THIS ISSUE (MDQ-CAPA-(B)(4)). THE SAMPLES WERE ALSO SENT TO THE SUPPLIER IN ORDER TO PERFORM THEIR INVESTIGATION. ACCORDING TO THE LABEL INSTRUCTIONS, THE USER IS TO SQUEEZE THE BAG TO ALLOW THE FLUID TO FLOW. WE WILL CONTINUE TO MONITOR THE TRENDS AND TAKE FURTHER ACTIONS IF DEEMED NECESSARY. A BATCH REVIEW WAS PERFORMED, AND THERE WERE NO DEVIATIONS NOTED. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, AN MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TEN INTERLINK CONTINU-FLO SETS THAT HAD A NO FLOW AT THE DISTAL END OF THE SAMPLE. THE SAMPLE WAS SPIKED INTO A BAG, AND THE DRIP CHAMBER WAS SQUEEZED. THE REGULATING AND THE ON/OFF CLAMP WERE OPENED, AND THERE WAS NO LIQUID FLOW. THE PROCESS STEP IN WHICH THIS OCCURRED WAS DURING PRIMING, BUT PRIOR TO BEING USED ON A PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 3 OF 10 OF THE SAME REPORTED PROBLEM FROM THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERLINK CONTINU-FLO, 3 INJECTION SITES, LUER LOCK, 105" SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SHERBROOKE ST10C284

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN SOLUTION BAG