BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIMA ACCEL

    MDR report key: 3090358 · Received May 2, 2013

    Report

    Report Number
    1722028-2013-01169
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    February 12, 2013
    Report Date
    April 5, 2013
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK970005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE CUSTOMER DID NOT PROVIDE THE LOT NUMBER PERTAINING TO THIS EVENT,THEREFORE A DEVICE HISTORY RECORD (DHR) SEARCH COULD NOT BE CONDUCTED FOR THIS SPECIFIC INCIDENT. ALL LOTS MUST MEET ACCEPTANCE CRITERIA BEFORE RELEASE. THE CUSTOMER PROVIDED ELEVATED WBC DATA FOR MULTIPLE PROCEDURES. THE DATA FOR THESE PROCEDURAL EVENTS WAS ANALYZED AS A GROUPING. INVESTIGATION OF AVAILABLE RUN DATA FILES (RDFS)IDENTIFIED SEVERAL PROCEDURAL EVENTS, AS LISTED BELOW, THAT MAY HAVE LED TO ELEVATED WBC LEVELS IN COLLECTED PRODUCT. ROOT CAUSE: RDFS FOR THE PROCEDURES WITH HIGH RWBC WERE RECEIVED, INVESTIGATED AND ANALYZED. THE DIFFERENT TYPES OF EVENTS THAT LED TO ELEVATED WBC CONTENT IN PLATELET PRODUCTS WERE IDENTIFIED AND ARE AS FOLLOWS: PRE-PURGE SATURATIONS - SIGNALS IN THE RDF SUGGEST THAT THE LRS CHAMBER HAS REACHED ITS WBC HOLDING CAPACITY BEFORE EXPECTED BY THE TRIMA ACCEL SYSTEM. POST-PURGE SATURATIONS - SIGNALS IN THE RDF SUGGEST THAT AFTER AN LRS PURGE, THE LRS CHAMBER HAS RE-FILLED WITH WBCS BEFORE EXPECTED BY THE TRIMA ACCEL SYSTEM. PLASMA LINE OCCLUSIONS - SIGNALS IN THE RDF SUGGEST THAT THE PLASMA LINE WAS PARTIALLY OCCLUDED DURING A PORTION OF THE PROCEDURE. THIS CAN CAUSE FLOW THROUGH THE LRS CHAMBER TO BE HIGHER THAN EXPECTED, DECREASING THE HOLDING CAPACITY OF THE LRS CHAMBER. OTHER EVENTS - THESE CAN INCLUDE; CENTRIFUGE STOPS, MULTIPLE ACCESS ALARMS & FLOW ADJUSTMENTS THAT CAN CONTRIBUTE TO A NON STEADY STATE CHAMBER CONDITIONS, AND RBC SPILLOVER SWITCH CAN POSSIBLY LEAD TO A HIGHER THAN EXPECTED WBC CONTENT. ALSO INCLUDED ARE DONOR RELATED CHARACTERISTICS. CORRECTION: A TRIMA SOFTWARE VERSION UPGRADE HAS BEEN COMPLETED AT ALL OF THE CUSTOMER¿S CENTERS. THE CUSTOMER PROVIDED DATA GATHERED FROM A TERUMO BCT RECOMMENDED TRIAL OF AVERAGING THE LAST 3 PLATELET COUNTS OF DONORS. THIS DATA SUGGESTS THAT USING THE AVERAGE PLATELET COUNT SHOWED A MORE CONSISTENT PROCESS, WHICH WILL REDUCE VARIATION SHOWN TO CONTRIBUTE TOWARDS RWBC FAILURES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN ELEVATED WHITE BLOOD CELL (WBC) CONTENT IN THE DOUBLE PLATELET PRODUCT AT THEIR (B)(6) SITE. THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF THE RESIDUAL WBC TESTING, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. THE DISPOSABLE SET IS UNAVAILABLE FOR RETURN BECAUSE THE CUSTOMER DISCARDED IT. 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
    191196 TRIMA ACCEL TRIMA ACCEL PLATELET, PLASMA TUBING SET, UK GKT TERUMO BCT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other