BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CL NON-DEHP CONTINU-FLO SET10 DPM, 110", 3 CL SITES

    MDR report key: 2021750 · Received March 17, 2011

    Report

    Report Number
    6000001-2011-01930
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 23, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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 PRODUCT CODE 2H8537 (LOT UNKNOWN), ONE USED SAMPLE OF PRODUCT CODE 2C7461 (LOT SR10K24022), AND ONE USED SAMPLE OF PRODUCT CODE 2C7461 (LOT UNKNOWN). THE PRIMARY 2H8537 SET ARRIVED PRIMED. BOTH OF THE 2C7461 SECONDARY SETS ARRIVED PRIMED, THE BLUE HANGERS WERE NOT RETURNED. THE 2H8537 WAS SPIKED INTO A 1000ML SOLUTION BAG CONTAINING STERILE WATER AND RE-PRIMED. BOTH 2C7461 SECONDARY SETS WERE SPIKED INTO A 1000ML SOLUTION BAG AND ALSO RE-PRIMED. EACH 2C7461 SECONDARY SET WAS THEN ATTACHED TO EACH OF THE CLEARLINK Y SITES AND CHECKED FOR FLOW. ALL THREE Y SITES FLOWED NORMALLY. ALSO NO BACK FLOW WAS NOTED. ADDITIONALLY, THERE WERE NO OBVIOUS VISUAL DEFECTS WERE NOTED ON ANY OF THE DEVISES. BECAUSE ALL SETS PRIMED AND FLOWED NORMALLY, THE COMPLAINT WILL NOT BE CONFIRMED. THEREFORE, NO ASSIGNABLE ROOT CAUSE COULD BE DETERMINED. 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 CORPORATE PRODUCT SURVEILLANCE THAT THE UPPER Y-SITE OF THE CLEARLINK NON-DEHP CONTINU-FLO SET, PRODUCT CODE 2H8537, LOT NUMBER UNKNOWN, WOULD NOT ALLOW FLOW AFTER CONNECTING A CLEARLINK SECONDARY MEDICATION SET, PRODUCT CODE 2C7461, LOT NUMBER UNKNOWN. THE CONDITION OCCURRED DURING PRIMING WITH NORMAL SALINE AND A BAXTER COLLEAGUE 3 PUMP WAS USED. THEY WERE ABLE TO ESTABLISH FLOW THROUGH THE 2C7461 PRIOR TO CONNECTING IT TO THE 2H8537. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CL NON-DEHP CONTINU-FLO SET10 DPM, 110", 3 CL SITES SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 CLEARLINK SECONDARY MEDICATION SET