Events

Recall of Terumo CDI Blood Parameter Monitoring System 500(Heart lung bypass in line blood gas monitor module)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Terumo Australia Pty Ltd.

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
    RC-2016-RN-00487-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-04-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00487-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    The bpm sensor head assembly’s thermistor, which provides the blood temperature value does not meet specification. this may cause inaccurate temperature measurement and inaccurate analyte display values. the thermistor measurement takes longer to reach actual temperature and temperature measurements at the extremes (18°c and 37°c) are the most inaccurate. lowest temperature displayed was about 19°c for the thermistor when a different thermistor measured the temperature near 15°c. highest temperature displayed was about 32°c when a different thermistor measured about 37°c. inaccurate temperature measurement could also cause inaccurate measurements of other bpm values including potassium (k+), po2, pco2, and ph. the algorithms for these parameters rely on temperature for the calculations. inaccurate measurement of these values could result in inappropriate patient management. there have been no reports of injury.
  • Action
    Terumo is advising users they can either; - Stop using the affected devices and return them to Terumo for repair. A loan unit will be provided until the corrected devices can be returned, OR - Continue to use the affected devices only for HSTAT monitoring functions until the replacement parts are available. These functions are unaffected by the issue. Once the replacement sensor heads are available, the devices should be returned to Terumo for repair. This action has been closed-out on 10/05/2017.

Device

Terumo CDI Blood Parameter Monitoring System 500(Heart lung bypass in line blood gas monitor module)
  • Model / Serial
    Terumo CDI Blood Parameter Monitoring System 500(Heart lung bypass in line blood gas monitor module)Catalogue numbers.: 500AHCT & 500AVHCTSerial numbers: 1899, 1948, 2473, 8001ARTG Number: 94012
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Terumo Australia Pty Ltd

Manufacturer

Terumo Australia Pty Ltd