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

Recall

RC-2016-RN-00487-1

Class I

2016-04-28

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00487-1

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.

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.