BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CL NON-DEHP SEC. MED SET LUERLOCK & HANGER NO DISTAL CONNEC

    MDR report key: 1982489 · Received February 9, 2011

    Report

    Report Number
    6000001-2011-00763
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 18, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS UNKNOWN IF A SAMPLE IS AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CORPORATE PRODUCT SURVEILLANCE THAT THE CLEARLINK NON-DEHP SECONDARY SET STOPS FLOWING WHEN THERE IS 2" LEFT IN THE SECONDARY MEDICATION BAG WITH CHEMO. THE PRIMARY SET AND SOLUTION BAG BEGINS TO FLOW BEFORE THE SECONDARY BAG IS EMPTY. 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 SEC. MED SET LUERLOCK & HANGER NO DISTAL CONNEC SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 CHEMOTHERAPY