Recall of TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM VERSION 5.0

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by TERUMO BCT INC..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    22769
  • Event Risk Class
    II
  • Event Initiated Date
    2013-04-24
  • Event Country
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    There is the potential risk for an air embolism if air is delivered to a donor due to the failure mode of operator error in which the donor is connected prior to completion of loading the tubing set when using the trima accel system. terumo bct is aware of nine reported events related to this failure mode. given this potential risk terumo bct is voluntarily implementing a safety enhancement in the trima accel system software version 5.1.9 and version 6.0.6 that modifies the current product bag air removal and tubing set test sequence. the safety enhancement is called air reduction mitigation (arm).

Device

  • Model / Serial
    Model Catalog: 81000 (Lot serial: > 10 numbers contact mfg); Model Catalog: 917000-000 (Lot serial: > 10 numbers contact mfg)
  • Product Description
    TRIMA ACCEL AUTOMATED BLOOD COLLECTION SYSTEM
  • Manufacturer

Manufacturer

  • Manufacturer Address
    LAKEWOOD
  • Manufacturer Parent Company (2017)
  • Source
    HC