BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2082267 · Received May 9, 2011

    Report

    Report Number
    6000001-2011-03805
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 12, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FPA
    PMA / PMN Number
    K003225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    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). A BATCH REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. 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 AN UNKNOWN QUANTITY OF LUER ACTIVATED VALVES FOR IV ACCESS THAT ARE THOUGHT TO BE INVOLVED IN CAUSING HEMOLYSIS. THE REPORTER STATED, "I'M INTERESTED IN THE CAP ITSELF CAUSING HEMOLYSIS WHEN DRAWING BLOOD THROUGH IT." THE REPORTER ALLEGED THAT WHEN THE ED NURSES INITIATE IV'S THEY DRAW LABS RIGHT AWAY THROUGH THE EXTENSION TUBING AND CAP. ACCORDING TO THE REPORT, THE PROCESS USED AT THE FACILITY IS THE IV IS INSERTED INTO THE PATIENT AND IS USED WITH THE EXTENSION SET WHICH CONTAINS THE CLEARLINK LUER. THEY THEN ATTACH THE VACUTAINER (TUBING USED TO DRAW AND STORE BLOOD BEFORE IT REACHES THE LAB) TO THE END CAP OF THE CLEARLINK AND DRAW THE BLOOD. THEY ARE HAVING PROBLEM WITH HEMOLYSIS IN THE LAB AFTER THE BLOOD HAS BEEN DRAWN. THE REPORTER HAS RECEIVED NUMEROUS REPORTS THAT THE BLOOD IN THE VACUTAINER HAS HEMOLYZED BY THE TIME IT REACHED THE LAB FOR EVALUATION. THE CUSTOMER IS ALLEGING THAT THERE IS SOME CORRELATION BETWEEN THE CLEARLINK AND THE HEMOLYSIS OCCURRING IN THE VACUTAINERS. THE CONDITIONS WERE IDENTIFIED AFTER PATIENT USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THESE EVENTS. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 VACUTAINER