BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1992235 · Received February 15, 2011

    Report

    Report Number
    6000001-2011-01019
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 27, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A CUSTOMER REPORTED TO BAXTER PRODUCT SURVEILLANCE OF A CLEARLINK SET IN WHICH THERE WAS A LEAKAGE THAT OCCURRED AT THE PROXIMAL Y-SITE NEAREST TO THE MALE LUER END. THE LEAKAGE OCCURRED ONCE RADIOACTIVE ISOTOPES WERE INJECTED INTO THE Y-SITE BY AN UNKNOWN SYRINGE DURING PRIMING. THIS SET WAS ALSO PRIMED WITH LACTATED RINGERS. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS 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 THE SAMPLE IS AVAILABLE FOR EVALUATION. HOWEVER, IF A SAMPLE IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION HAS BEEN PERFORMED. THE BATCH REVIEW CANNOT BE PERFORMED SINCE THERE WAS NO LOT NUMBER PROVIDED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO A BAXTER SALES REPRESENTATIVE (BSR) OF A CLEARLINK SET IN WHICH LEAKING WAS DETECTED BETWEEN THE MALE LUER CONNECTOR AND THE STERILE CAP ON THE END OF THE TUBING AFTER PRIMING WITH RADIOACTIVE ISOTOPES. PRIMING IS DONE IN THE STRESS ROOM, AND DRIPS ON THE FLOOR CANNOT BE DIFFERENTIATED FROM FLUID DUE TO OTHER PROCEDURES. THERE WAS NO REPORTED PATIENT INJURY OR MEDICAL INTERVENTION INVOLVED. 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 RADIOACTIVE ISOTOPES| UNKNOWN SYRINGE, LACTATED RINGERS