BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIMA ACCEL SYSTEM

    MDR report key: 6621499 · Received June 5, 2017

    Report

    Report Number
    MW5070244
    Event Type
    Injury
    Date Received
    June 5, 2017
    Date of Event
    May 3, 2017
    Report Date
    June 5, 2017
    Manufacturer
    TERUMO BCT INC.
    Product Code
    GKT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2017, THE TERUMO BCT TRIMA ACCEL SYSTEM (DEVICE SN (B)(4)) ALLOWED AN APHERESIS OPERATOR TO COLLECT A 2RBC (DOUBLE RBC) PRODUCT (BAG 1 WAS 326ML AND BAG 2 WAS 432ML) AND A 264ML PLASMA, THIS PROCEDURE IS NOT ONE THAT IS ON OUR PROCEDURE LIST AND IS NOT ONE THAT WOULD EVER BE ELECTED TO PERFORM. ALTHOUGH THE OPERATOR INITIALLY SELECTED A PLASMA PROCEDURE, 19 MINUTES INTO THE PROCEDURE, THE DEVICE ALLOWED THE OPERATOR TO CHANGE THE PROCEDURE TO A 2RBC WITH SINGLE PLASMA. FOLLOWING THE COLLECTION, THE OPERATOR REPORTED WHAT HAPPENED TO HIS MANAGER AND THE QUALITY DEPARTMENT AND AN INVESTIGATION BEGAN. A ROOT CAUSE ANALYSIS EVENT WAS HELD ON (B)(6) 2017 INTERNALLY AT INOVA BLOOD DONOR SERVICES REGARDING THE PROCEDURE AND THE INCIDENT WAS REPORTED TO TERUMO FOR FURTHER INVESTIGATION. TERUMO'S REPORT TOOK SEVERAL DAYS AND THEIR FINAL STANCE ON THE PROCEDURE WAS THAT THE "TRIMA ACCEL ACTED AS INTENDED" AND THEIR ORGANIZATION HAD OBSERVED ISSUES SIMILAR TO THIS IN THE PAST BUT DIDN'T FEEL THERE WAS A NEED TO NOTIFY ANY CUSTOMERS OR CHANGE ANY OF THEIR BUSINESS PRACTICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394538 TRIMA ACCEL SYSTEM SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC GKT TERUMO BCT INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other| R