BEUDAMED
    FDA Adverse Event Summary report: N

    TRIMA ACCEL

    MDR report key: 3183164 · Received June 21, 2013

    Report

    Report Number
    1722028-2013-01259
    Date Received
    June 21, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 24, 2013
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK120017
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: TWO SETS WERE RECEIVED FOR EVALUATION. INITIAL VISUAL INSPECTION REVEALED NO ABNORMALITIES. INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THIS UNIT SHOWED NO IRREGULARITIES DURING MANUFACTURING THAT WERE RELEVANT TO THIS ISSUE. PREVENTIVE MAINTENANCE WAS CONDUCTED ON THE MACHINES TWO DAYS PRIOR TO THE INCIDENT. THE MACHINES WERE CLEARED FOR USE AT THAT TIME. THE CUSTOMER WAS NOT ABLE TO CONFIRM DATES AND CORRESPONDING SERIAL NUMBERS FOR THE ALARMS REPORTED IN THIS COMPLAINT. ANALYSIS OF DATA LOGS COULD NOT BE COMPLETED. THE NONRECOVERABLE ALARMS THAT WERE RECEIVED WERE "LOW LEVEL DETECTOR ERROR", "PRESSURE SENSOR ERROR", AND "#55".ROOT CAUSE: THERE WERE NO ISSUES FOUND WITH THE RETURNED SETS. HOWEVER, IT WAS NOT APPARENT WHICH ALARM WAS ASSOCIATED WITH THE RETURNED SETS. INVESTIGATION INTO THE PRESSURE SENSOR ALARM DID NOT FIND A DEFINITIVE ROOT CAUSE FOR THE OCCURRENCE. THE TIME OF THE ALARM OCCURRENCE SUGGESTS THIS ISSUE IS MOST LIKELY CAUSED BY (BUT NOT LIMITED TO) THE FOLLOWING:-DILUTED OR CONTAMINATED DIAPHRAGM/DISC ADHESIVE-MANUFACTURING PROCESS RESIDUAL ON THE DIAPHRAGM AND/OR DISC-INSUFFICIENT DIAPHRAGM SURFACE TREATMENT-VENDOR COMPONENT MANUFACTURING PROCESS ISSUE-SUBASSEMBLY MANUFACTURING PROCESS ISSUE DEFINITIVE CAUSE OF FIRST CYCLE ERRORS (ALARM #55) REMAINS UNDETERMINED AT THIS TIME. THIS ALARM IS GENERATED BY AN EARLY DETECTION OF FLUID AT THE UPPER LEVEL SENSOR. POTENTIAL CAUSES INCLUDE BUT ARE NOT LIMITED TO:- AIR BLOCK IN PLASMA LINE- CENTRIFUGE WAS STOPPED DURING FIRST CYCLE- UPPER LEVEL SENSOR REQUIRES CLEANING- AN OPERATOR SPIKING THE AC PRIOR TO THE SYSTEM PROMPT- VARIATIONS IN THE DISPOSABLE SET- SOFTWARE INTERPRETATION OF THE LEVEL SENSOR SIGNAL TRIGGERS ALARM THE ROOT CAUSE FOR THE LEVEL SENSOR ALARM IS INCONCLUSIVE AT THIS TIME. POSSIBLE CAUSES INCLUDE BUT ARE NOT LIMITED TO:- CENTRIFUGE WAS STOPPED BY THE OPERATOR OR AN ALARM JUST PRIOR TO THIS ALERT- PARTIAL OBSTRUCTION TO THE ACCESS LINE- AIR BLOCK AT PLASMA LINE DURING RBC COLLECTION- TUBING SET LEAK OR RESTRICTION TO DRAW FLOW- DEFECTIVE INLET PUMP OR INLET PUMP OCCLUSION- FLUID TRAPPED IN UPPER PORTION OF LEVEL SENSOR RESERVOIR TERUMO BCT IS CURRENTLY INVESTIGATING INTERNAL PROCESSES IN ADDITION TO WORKING WITH COMPONENT VENDORS TO EVALUATE POTENTIAL ACTIONS TO REDUCE THE LIKELIHOOD OF THE PRESSURE SENSOR ALARMS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF THIS INCIDENT, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON SIX OCCASIONS, THE PROCEDURE HAD TO BE STOPPED WHILE STARTING THE COLLECTION DUE TO MULTIPLE ALARMS. THE PATIENT WEIGHT IS NOT AVAILABLE AT THIS TIME. THIS REPORT IS BEING FILED IN RESPONSE TO THE CUSTOMER FILING A SAE REPORT WITH THEIR LOCAL AUTHORITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282710 TRIMA ACCEL TRIMA ACCEL PLATELET, PLASMA, RBC , PAS, TLR SET GKT TERUMO BCT 02V3122

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR