BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1941535 · Received December 29, 2010

    Report

    Report Number
    6000001-2010-06375
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 6, 2010
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL: THE SAMPLE IS NOT AVAILABLE FOR EVALUATION, THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. HOWEVER, A BATCH REVIEW WAS PERFORMED ON THE REPORTED LOT AND NO DEVIATIONS WERE NOTED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER IN REGARDS TO A CLEARLINK NON-DEHP CONTINU-FLO SOLUTION SET. WHEN THE NURSE CLAMPED OFF THE BLUE SLIDE CLAMP, IT APPEARED THAT THE BLUE SLIDE CLAMP SLIT THE TUBING OPEN AND CAUSED LEAKING. THE SET WAS RUNNING NORMAL SALINE AT THE TIME OF THE INCIDENT. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION. 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 R10J01048

    Patients

    Seq Age Sex Outcome Treatment
    1 NORMAL SALINE