BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIMA ACCEL

    MDR report key: 6196597 · Received December 21, 2016

    Report

    Report Number
    1722028-2016-00660
    Event Type
    Malfunction
    Date Received
    December 21, 2016
    Date of Event
    December 5, 2016
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK120049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: ONE YEAR OF SERVICE HISTORY WAS REVIEWED FOR THIS DEVICE WITH NO PROBLEMS IDENTIFIED RELATED TO THE REPORTED CONDITION. AN INTERNAL REPORT SHOWS THAT THE MACHINE HAS BEEN IN USE WITH NO FURTHER OCCURRENCES OF THE PROBLEM. ROOT CAUSE: THE ROOT CAUSE OF THIS FAILURE WAS A LOOSE RELEASE BOLT ON THE IV POLE. CORRECTION: TRIMA FIELD ACTION 30 HAS BEEN INITIATED TO NOTIFY ALL TRIMA USERS TO USE PRECAUTION WHILE TRANSPORTING THE DEVICE AND A CAUTION STATEMENT WAS INCLUDED IN THE OPERATOR'S MANUAL. CORRECTIVE ACTION: AN INTERNAL CAPA HAS BEEN INITIATED TO EVALUATE REPORTS OF THE IV POLE DROPPING DOWN SUDDENLY.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: A SERVICE CALL WAS PLACED AND A TERUMO BCT SERVICE TECHNICIAN VISUALLY INSPECTED THE DEVICE AT THE CUSTOMER SITE. THE SERVICE TECHNICIAN NOTED A LOOSE BOLT ON THE IV POLE. THE BOLT WAS ADJUSTED BY REPLACING AND TIGHTENING THE LOCK NUT. AN AUTOTEST WAS SUCCESSFULLY PERFORMED. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER DECLINED TO PROVIDE PATIENT INFORMATION. DURING CUSTOMER FOLLOW-UP, THE CUSTOMER STATED THAT NO ADVERSE EVENT OCCURRED AND NO MEDICAL INTERVENTION WAS REQUIRED FOR THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A COLLECTION PROCEDURE, THE IV POLE ON THE TRIMA EQUIPMENT UNEXPECTEDLY LOWERS DOWN. IT IS UNKNOWN AT THIS TIME IF MEDICAL INTERVENTION WAS REQUIRED FOR THIS EVENT. INFORMATION OF PATIENT (DONOR) OR OPERATOR OF THE DEVICE IS NOT KNOWN AT THIS TIME. OUTCOME OF PATIENT (DONOR) OR OPERATOR OF THE DEVICE IS NOT KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846803 TRIMA ACCEL TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM GKT TERUMO BCT 81000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other