BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIMA ACCEL

    MDR report key: 3942683 · Received July 17, 2014

    Report

    Report Number
    1722028-2014-00275
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 22, 2014
    Report Date
    June 23, 2014
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK120049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: PER THE CUSTOMER, DURING LOADING OF THE TUBING SET A 'PRESSURE TEST ERROR' WAS RECEIVED, THE OPERATOR UNLOADED AND RELOADED THE TUBING SET IN RESPONSE TO THE ALERT. CUSTOMER DOES NOT KNOW WHAT CAUSED THE AIR IN THE BAG. A SERVICE CALL HAS BEEN PLACED TO CHECK THE TRIMA. THE RUN DATA FILES WERE REVIEWED AND IT WAS CONFIRMED THAT A PRESSURE TEST ERROR WAS DISPLAYED WHEN THE SET LOAD WAS ATTEMPTED, AND THAT THE SET WAS UNLOADED, RELOADED WITH PRIME COMPLETED. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL EVALUATION METHOD CODE: STERILIZATION PROCESS REVIEW INVESTIGATION: TERUMO BCT SERVICE TECHNICIAN PERFORMED A FULL FUNCTIONAL CHECK INCLUDING SALINE RUN WITH NO ISSUES. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THIS UNIT SHOWED NO IRREGULARITIES DURING MANUFACTURING THAT WERE RELEVANT TO THIS ISSUE. THE SET WAS NOT AVAILABLE FOR ANALYSIS. HOWEVER, A PICTURE WAS SENT IN AND SHOWS THAT THE SAMPLE BAG IS FILLED WITH AIR. THE SAMPLE BAG CLAMP IS NOTED AS BEING CLOSED. ROOT CAUSE: THE SIGNALS IN THE RUN DATA FILE INDICATE THAT THE TRIMA ACCEL SYSTEM OPERATED AS INTENDED BY DISPLAYING THE ¿PRESSURE TEST ERROR¿ ALERT WHEN THE SYSTEM COULD NOT REACH PRESSURE DURING THE TUBING SET TEST. THE TRIMA ACCEL DEVICE WAS FUNCTIONALLY CHECKED AND NO UNUSUAL PROCESS VARIABLES WERE FOUND. THE TRIMA ACCEL TUBING SET WAS NOT RETURNED FOR INVESTIGATION BUT THE PICTURE CONFIRMED A FULLY INFLATED SAMPLE BAG. IF THE OPERATOR DOES NOT CLOSE THE CLAMPS ON THE TRIMA ACCEL SYSTEM WHEN INSTRUCTED BY THE SYSTEM, OR IF THE CLAMPS DO NOT PROPERLY OCCLUDE THE TUBING DURING THE TUBING SET TEST, AIR MAY BE INTRODUCED INTO THE SAMPLE BAG. IF THE OPERATOR DOES NOT OPEN THE DONOR LINE CLAMP TO RELIEVE PRESSURE AS INSTRUCTED BY THE SYSTEM, THE OPERATOR WILL NOT BE ABLE TO CONTINUE AND THE ONLY OPTION WILL BE TO UNLOAD THE CASSETTE. IF THE OPERATOR THEN UNLOADS AND RELOADS THE SET AND PROCEEDS TO DONOR CONNECTION WITHOUT EXPRESSING AIR FROM THE SAMPLE BAG, THE AIR WILL BE RETURNED TO THE DONOR. CORRECTION: A VOLUNTARY MEDICAL DEVICE PRODUCT RECALL WAS RELEASED BY TERUMO BCT ON (B)(6) 2014 TO COMMUNICATE MORE INFORMATION ABOUT THE "AIR IN THE SAMPLE BAG SAFETY ALERT" TO THE CUSTOMER. CORRECTIVE/PREVENTIVE ACTION: AN INTERNAL CAPA HAS BEEN INITIATED TO ADDRESS CORRECTIVE AND PREVENTATIVE ACTIONS FOR AIR IN THE SAMPLE BAG.

    Additional Manufacturer Narrative · 1

    THIS RECORD WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF MDRS TO IDENTIFY RECORDS IN WHICH AN EVENT OCCURRED, BUT THE TYPE OF REPORTABLE EVENT WAS NOT INDICATED APPROPRIATELY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AFTER THE VENIPUNCTURE OF A PLASMA DONOR, THE OPERATOR OPENED THE 2 WHITE CLAMPS TO ALLOW BLOOD FLOW INTO THE SAMPLE BAG. THE OPERATOR NOTICED SOME AIR IN THE SAMPLE BAG AND THE BLOOD REMAINED AT THE NEEDLE LINE AND IT DID NOT FLOW INTO THE SAMPLE BAG. THE OPERATOR THEN NOTICED THAT THE SAMPLE BAG WAS FULL OF AIR. PER THE CUSTOMER, THE OPERATOR DISCONTINUED THE PROCEDURE AND DOES NOT BELIEVE THE DONOR RECEIVED INFUSION OF ANY AIR. THE DONOR REMAINED AT THE SITE FOR 15 MINUTES, THE DONOR FELT 'FINE' AND LEFT WITHOUT A PROBLEM. THE DONOR HAD A ROUTINE PHYSICAL NOT RELATED TO THE INCIDENT. ALL RESULTS CAME BACK NORMAL. THE DISPOSABLE KIT IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER. THIS REPORT IS BEING FILED DUE TO INSUFFICIENT INFORMATION PROVIDED AT THIS TIME TO DETERMINE IF A MALFUNCTION WITH THE POTENTIAL FOR INJURY HAS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418761 TRIMA ACCEL TRIMA ACCEL MULTIPLASMA SET GKT TERUMO BCT 03W2117

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other