BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK DUO-VENT C-FLO SET10 DPM DUO-VENT

    MDR report key: 1935566 · Received December 22, 2010

    Report

    Report Number
    6000001-2010-06106
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    November 29, 2010
    Report Date
    November 29, 2010
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RETURNED FOR EVALUATION; HOWEVER, IT HAS NOT YET BEEN COMPLETED. ONCE THE EVALUATION IS COMPLETE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER RETURNED ONE USED SAMPLE OF (B)(4), LOT UNKNOWN. THE SAMPLE ARRIVED SPIKED INTO AN EMPTY 100ML (B)(4) SOLUTION BAG WITH A PATIENT LABEL. THE SET HAD BEEN FULLY PRIMED. A PRIMED (B)(4) SECONDARY SET WAS ATTACHED TO THE TOP Y SITE AND SPIKED INTO A HALF EMPTY (B)(4) SOLUTION BAG. THE BLUE HANGER WAS NOT RETURNED. ALL THREE Y SITES WERE VISUALLY INSPECTED UNDER A MICROSCOPE FOR PRESENCE OF THE CENTER SLIT PRIOR TO RE-PRIMING AND FLOW CHECK. THE CENTER SLITS IN ALL THREE Y SITES WERE OPEN. THE (B)(4) PRIMARY SET WAS THEN SPIKED INTO A 1000ML SOLUTION BAG CONTAINING REVERSE (B)(6) WATER AND RE-PRIMED. THE (B)(4) SECONDARY SET WAS SPIKED INTO A 500ML SOLUTION BAG ALSO CONTAINING REVERSE (B)(6) WATER AND RE-PRIMED. ALL THREE Y SITES WERE THEN CHECKED FOR FLOW. ALL THREE Y SITES FUNCTIONED NORMALLY WITH NORMAL FLOW NOTED. THE MALE LUER OF THE (B)(4) SECONDARY SET WAS ALSO VISUALLY INSPECTED FOR ANY ABNORMALITIES WITH NONE FOUND. BECAUSE THE SAMPLE PERFORMED AS DESIGNED THE COMPLAINT WILL NOT BE CONFIRMED. THEREFORE, AN ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. A BATCH REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER OF A NO FLOW THAT OCCURRED AT THE UPPER Y-SITE OF THE CLEARLINK DUO-VENT CONTINU-FLO SET DURING PATIENT USE. THE NURSE WAS ABLE TO GET FLOW WHEN SHE TRIED DISCONNECTING AND RECONNECTING THE MALE LUER OF THE SECONDARY MED SET. THE NURSE WAS UNSURE IF SHE HAD FULLY SEATED THE LUER, BUT SHE DID REPORT SWABBING THE VALVE PRIOR TO INITIAL ACCESS. 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 DUO-VENT C-FLO SET10 DPM DUO-VENT SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PRIMARY SET