BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIMA ACCEL

    MDR report key: 3061835 · Received April 16, 2013

    Report

    Report Number
    1722028-2013-01119
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 20, 2013
    Report Date
    March 20, 2013
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK120017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION. INVESTIGATION: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THIS UNIT SHOWED NO IRREGULARITIES DURING MANUFACTURING THAT WERE RELEVANT TO THIS ISSUE. A REVIEW OF THE LOT FOR SIMILAR REPORTS WAS CARRIED OUT, NONE HAVE BEEN REPORTED. ROOT CAUSE: ROOT CAUSE REMAINS UNDETERMINED AT THIS TIME. THE RUN DATA FILE ANALYSIS AND INVESTIGATION OF THE RETURNED DISPOSABLES SET DO NOT SHOW A CLEAR CAUSE FOR THE AC BACK FLOW REPORTED IN THIS CASE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE DISPOSABLE SET WAS RECEIVED FOR EVALUATION. THE TUBING FROM THE SAMPLE POUCH TO THE Y CONNECTOR HAD 3 PERMANENT SEALS ON IT. THERE WAS NO BLOOD IN THE ACCESS NEEDLE TUBING, ONLY A SMALL AMOUNT OF ACD-A. THE 2 WHITE AND 1 BLUE PINCH CLAMPS NEAR THE MANIFOLD WERE ATTACHED TO THE CORRECT TUBING. THE BAG TUBING AND INLET COIL TUBING WERE ATTACHED TO THE CASSETTE IN THE PROPER CONFIGURATION. THE CHANNEL APPEARED TO HAVE BEEN ASSEMBLED CORRECTLY. THE BAGS DID NOT APPEAR TO HAVE EXCESSIVE AIR IN THEM. THE SET WAS TAKEN APART AND IT WAS FOUND TO BE ASSEMBLED CORRECTLY. THE AC TUBING AND FILTER WERE CHECKED FOR OCCLUSION AND NONE WAS FOUND. THE RUN DATA FILE WAS ANALYZED FOR THIS EVENT. SIGNALS IN THE FILE INDICATE A DROP IN PRESSURE OCCURRED WHEN THE SYSTEM ENTERED THE 'DONOR CONNECTED' STATE WHEN NO PUMPS WERE MOVING. THE CAUSE FOR THIS PRESSURE DROP AND SUBSEQUENT FLOW OF AC TOWARD THE DONOR IS UNKNOWN AT THIS TIME. 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. ROOT CAUSE: THE PRESSURE INSIDE THE SET REMAINED NEGATIVE AND CONTINUED TO BECOME MORE NEGATIVE. THUS, IT IS NOT POSSIBLE FOR FLUID TO HAVE BEEN PUSHED BACK TOWARD THE DONOR. BASED ON OUR INTERNAL TESTING, IT IS LIKELY THAT THE CLAMPING AND UNCLAMPING OF THE TUBING WAS NOT FOLLOWED AS PROMPTED BY THE TRIMA ACCEL SYSTEM. THIS CAN CAUSE THE PRIME FLUID IN THE TUBING TO MOVE. IT IS LIKELY THAT THE OPERATOR NOTICED THIS OCCURRING AND MISUNDERSTOOD WHAT HAD HAPPENED AND DISCONTINUED THE PROCEDURE AT THAT TIME.

    Description of Event or Problem · 1

    PATIENT IDENTIFIER AND AGE REMAIN UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A SMALL AMOUNT OF ANTICOAGULANT (AC) WAS FLOWING BACK TO THE DONOR WHEN THE BLUE CLAMP WAS OPENED. THE CUSTOMER SET UP AND PRIMED THE TRIMA WITHOUT INCIDENT. SHE STATED SHE COLLECTED THE SAMPLE IN THE SAMPLE BAG WITHOUT ANY PROBLEM. AFTER THE BLUE CLAMP WAS OPENED PER PROTOCOL, SHE NOTICED THAT THE AC WAS FLOWING BACK TO THE DONOR. SHE IMMEDIATELY CLAMPED THE LINE AND DISCONTINUED THE PROCEDURE. PATIENT IDENTIFIER AND AGE ARE NOT AVAILABLE AT THIS TIME. THIS REPORT IS BEING FILED DUE TO DEVICE MALFUNCTION THAT HAS THE POTENTIAL FOR INJURY.

    Description of Event or Problem · 1

    PATIENT'S FULL ID IS (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162717 TRIMA ACCEL TRIMA ACCEL ENHANCED PLT, PLS, RBC SET GKT TERUMO BCT 01V3119

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other