Events

Safety Alert for Spectra Optia Apheresis 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
    2015-09-01
  • Event Date Posted
    2015-09-01
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150901b.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 spectra optia apheresis systems medical device manufacturer, terumo bct, has issued a medical device safety alert concerning its spectra optia apheresis systems. the manufacturer has received reports of data entry errors that cause the system to calculate a patient total blood volume (tbv) that is abnormal for that specific patient. the error can occur under the following circumstances:   the operator accidentally switches the values for height and weight when entering the data.   the patient is weighed and measured in units that are different from what the operator selects when entering the data.    the operator enters a height and a weight that are not accurate. if the operator does not enter correct data, the patient may receive excess anticoagulant (ac) or the outcome of the procedure may be affected. this issue can have the greatest effect on small or compromised patients for whom an abnormally high tbv calculation could lead to hypocalcemia. the manufacturer instructs affected users to review and confirm the data entered on the systems screens before connecting the patient to the system and throughout the procedure. the manufacturer will also provide software upgrade to mitigate the potential for data entry errors. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 1 september 2015.

Device

Spectra Optia Apheresis System
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Terumo BCT Spectra Optia Apheresis Systems
  • Manufacturer
    Terumo BCT

Manufacturer

Terumo BCT