BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUFLEX BLOOD BAG SYSTEM

    MDR report key: 3130007 · Received May 24, 2013

    Report

    Report Number
    1722028-2013-01218
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 29, 2013
    Manufacturer
    TERUMO CORPORATION/TERUMO BCT
    Product Code
    KSR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: PER THE CUSTOMER, THE HEMOLYSIS IS NOTED IN THE PLASMA, AFTER THE 1ST SOFT SPIN. THEY HAVE NOT FORMALLY TESTED THE UNITS FOR HEMOLYSIS, BUT THEY MEET THE VISUAL CRITERIA FOR HEMOLYSIS. THE CUSTOMER STATES THAT WHILE INVESTIGATING INTERNALLY, THEY HAD MADE A CHANGE TO THE WAY THEY WERE STRIPPING THE TUBING AFTER COLLECTION. SINCE THAT WAS THE ONLY VARIABLE, THEY NOTED THAT HAS CHANGED, THEY WENT BACK TO THE PRIOR WAY OF STRIPPING THE TUBING TO SEE IF THE INCIDENTS OF CLOTTING AND/OR HEMOLYSIS WOULD STOP OR DECLINE. INVESTIGATION, EVALUATION, AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION. INVESTIGATION:THE DISPOSABLE SETS WERE RECEIVED FOR EVALUATION. SAMPLES TAKEN FROM THE RETURNED SETS WERE USED FOR HEMOLYSIS TESTING, WITH HEMOLYSIS FOUND. RESERVE SAMPLES FOR THIS LOT WERE VISUALLY EXAMINED, AND THE SOLUTION VOLUME AND SOLUTION COMPOSITION WERE TESTED, WITH NO ABNORMALITIES NOTED. THE MANUFACTURING AND TESTING RECORDS WERE REVIEWED. THE LOT CONFORMED TO ALL SPECIFICATIONS. ROOT CAUSE: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. HEMOLYSIS CAN BE CAUSED BY THE FOLLOWING:-CHARACTERISTICS OF BLOOD, E.G. RED BLOOD CELL FRAGILITY-BACTERIAL CONTAMINATION-EXCESSIVE COOLING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HEMOLYSIS IN TWO UNITS OF PLASMA. HEMOLYSIS IS BEING NOTED AFTER CENTRIFUGATION AND BEFORE FILTRATION. THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF THE WHOLE BLOOD CELL PROCESSING INTO PLASMA UNITS, THEREFORE, NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. THIS REPORT IS BEING FILED DUE TO A DEVICE MALFUNCTION THAT HAS THE POTENTIAL FOR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232167 TERUFLEX BLOOD BAG SYSTEM TERUFLEX CPD/OPTISOL 500ML TRIPLE BLOOD COLLECTION SET KSR TERUMO CORPORATION/TERUMO BCT 121126GB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other