BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK BURETROL SOLUTIONSET

    MDR report key: 1920212 · Received December 10, 2010

    Report

    Report Number
    6000001-2010-05710
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    October 28, 2010
    Report Date
    November 10, 2010
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K984381
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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.

    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER CORPORATE PRODUCT SURVEILLANCE OF A PROBLEM WITH THE CLEARLINK BURETROL SOLUTION SET. ANESTHESIA HAS BEEN REPORTING AIR IN LINE CAUSING BLOOD BACKING UP. THEY ARE USING THIS PRODUCT AS A SUBSTITUTE TO THE CUSTOM SET 3C0157. BAXTER REPRESENTATIVES AND CLINICAL SUPPORT HAVE BEEN IN THE HOSPITAL TO ENFORCE PROPER PRIMING AND CLAMPING. THE CUSTOMER EXPLAINED THAT THIS IS NOT A PRODUCT DEFECT, RATHER THE STAFF IS USED TO THE 3C0157 WHICH HAS A CHECKVALVE AND DOES NOT ALLOW FOR BLOOD BACKFLOW. THE CONDITION IS OCCURRING WHEN PATIENTS ARE TRANSPORTED FROM ONE AREA TO ANOTHER. IT OCCURS WHEN THE BURETROL IS EMPTY AND THE SOLUTION BAG IS RESTED ON THE PATIENT'S BED OR HUNG DURING TRANSPORT. THE STAFF IS NOT USED TO CLAMPING THE BURETROL SET PRIOR TO TRANSPORT, BUT IF IT IS CLAMPED THEY DO NOT HAVE ANY ISSUES. THE FACILITY HAS RECEIVED THE 3C0157 AGAIN AND DOES NOT HAVE TO PAY ATTENTION TO CLAMPING. 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 CLEARLINK BURETROL SOLUTIONSET SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1