BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIMA ACCEL

    MDR report key: 6092580 · Received November 10, 2016

    Report

    Report Number
    1722028-2016-00603
    Event Type
    Malfunction
    Date Received
    November 10, 2016
    Date of Event
    October 17, 2016
    Report Date
    November 10, 2016
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK150321
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE CUSTOMER STATED THAT THE COLLECTION SET FAILED DURING TUBING SET TEST. THE SET WAS RETESTED AND PASSED THE SECOND TIME. A TRIMA COLLECTION SET WAS RETURNED FOR INVESTIGATION. UPON VISUAL INSPECTION, IT WAS NOTED PRIME FLUID HAD CIRCULATED THROUGH THE INLET COIL AND INLET PUMP HEADER TUBE. NO FLUID OBSERVED IN THE LOOP, CHANNEL, REMAINDER OF CASSETTE, OR RETURN RESERVOIR. THE FOLLOWING CLAMPS WERE CLOSED UPON RECEIPT OF THE SET: WHITE PINCH CLAMP ON SAMPLE BAG LINE, WHITE PINCH CLAMP ON DONOR LINE, BLUE PINCH CLAMP ON DONOR LINE. IT WAS ALSO NOTED THAT A SMALL DEVIATION IN THE TUBING ALIGNMENT WAS OBSERVED IN THE BLUE PINCH CLAMP ON THE DONOR LINE. THE TUBING IN WHITE PINCH CLAMP GOING TO THE SAMPLE APPEARED TO BE ALIGNED PROPERLY. A SMALL AMOUNT OF AIR WAS OBSERVED IN THE SAMPLE BAG. VISUAL INSPECTION FOR KINKS, OCCLUSIONS, MISSING PARTS, MISASSEMBLY OR LEAKS WHICH MAY HAVE CONTRIBUTED TO THE REPORTED INCIDENT DID NOT REVEAL ANY ABNORMALITIES. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION IN DESCRIBE EVENT OR PROBLEM, EVALUATION CODES, AND ADDITIONAL MFR NARRATIVE. ADDITIONAL INVESTIGATION: TERUMO BCT TECHNICAL SERVICE REVIEWED AN INTERNAL REPORT AND CONFIRMED THAT THE 'START DRAW' BUTTON FOR THE PROCEDURE WAS NEVER PRESSED AND THERE WERE 3 PRESSURE TEST ERRORS GENERATED. UPDATED ROOT CAUSE: ROOT CAUSE REMAINS UNDETERMINED AT THIS TIME. POSSIBLE CAUSES INCLUDE BUT ARE NOT LIMITED TO: FAILURE TO CLOSE THE WHITE CLAMP ON THE SAMPLE BAG LINE, OR THE WHITE CLAMP ON THE SAMPLE BAG DID NOT PROPERLY OCCLUDE THE TUBING DURING THE INITIAL PRESSURE TEST.

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: ROOT CAUSE REMAINS UNDETERMINED AT THIS TIME. POSSIBLE CAUSES INCLUDE BUT ARE NOT LIMITED TO: FAILURE TO CLOSE THE WHITE CLAMP ON THE SAMPLE BAG LINE, OR THE WHITE CLAMP ON THE SAMPLE BAG DID NOT PROPERLY OCCLUDE THE TUBING DURING THE INITIAL PRESSURE TEST. CORRECTIVE ACTION: AN INTERNAL CAPA HAS BEEN INITIATED TO EVALUATE REPORTS OF AIR IN SAMPLE BAG.

    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. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE PERFORMING A PHLEBOTOMY ON THE DONOR FOR A COLLECTION PROCEDURE, THE OPERATOR NOTED THE SAMPLE BAG HAD FILLED WITH AIR. PATIENT'S (DONOR) FULL IDENTIFIER: (B)(6). THE CUSTOMER DECLINED TO PROVIDE PATIENT'S WEIGHT.

    Description of Event or Problem · 1

    DURING CUSTOMER FOLLOW-UP, THE CUSTOMER STATED THAT NO DONOR WAS CONNECTED AT THE TIME OF THE EVENT. THE INFORMATION INITIALLY PROVIDED BY THE CUSTOMER WAS FOR THE INTENDED DONOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744035 TRIMA ACCEL TRIMA ACCEL PLATELET, PLASMA, RBC SET GKT TERUMO BCT 09Z3209

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other