Events

Safety Alert for Trima Accel Automated Blood Collection System

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Terumo BCT.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2013-04-29
  • Event Date Posted
    2013-04-29
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130429.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: terumo bct trima accel automated blood collection system medical device manufacturer, terumo bct, has issued a field safety notice concerning trima accel automated blood collection system (catalogue number: 81000, serial number: all). terumo bct is voluntarily recalling the trima accel system for the addition of a safety enhancement called air reduction mitigation. this safety enhancement is being implemented to address the potential risk for an air embolism should a donor be prematurely connected to the trima accel system. they are aware of nine reported events related to this failure mode during the period of november 2008 to march 2013. in the current process, when the tubing set cassette is lowered, a small amount of air is forced out the needle line. once the cassette has completed lowering, the system then automatically begins removing air from the product bags. approximately 135 ml of air is pumped out of the needle line. the system then prompts theoperator to close the clamps on the needle line and the sample bag line to perform the tubing set test. if the instructions are not followed in proper sequence and the donor is connected prior to lowering the cassette, there is the potential risk for the air to be delivered to the donor. terumo bct is voluntarily implementing a safety enhancement in the trimaaccel system software version 5.1.9 and version 6.0.6 that modifies the current product bag air removal and tubing set test sequence. this new functionality will redirect the air from the product bags and cassette into the vent bag instead of out the needle line. a larger vent bag was implemented on tubing sets in december 2011 which accommodates this new functionality. the manufacturer advises users that during the time between this announcement and your center’s implementation of the arm functionality in version 5.1.9, upgrade to version 5.1.9 or upgrade to version 6.0.6, you should continue to use your trima accel system in accordance with the current operator’s manual. according to the manufacturer, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 29 april 2013.

Device

Trima Accel Automated Blood Collection System
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Terumo BCT Trima Accel Automated Blood Collection System
  • Manufacturer
    Terumo BCT

Manufacturer

Terumo BCT