CDI BLOOD PARAMETER MONITORING SYSTEM 500 (2016-03-16)

Starting date:

March 16, 2016

Posting date:

April 4, 2016

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-57742

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  Reason
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  Affected products

Affected Products

CDI BLOOD PARAMETER MONITORING SYSTEM 500

Reason

Specific CDI Blood Parameter Monitoring System 500 devices are being voluntarily recalled because the BPM sensor head assembly's thermistor, which provides the blood temperature value that results in accurate display values on the monitor, does not meet specification. This may cause inaccurate temperature measurement and inaccurate analyte display values on the CDI System 500 monitor.

Terumo Cardiovascular Systems (Ryan Medical Distributors Inc.) Received complaints of inaccurate temperature measurements for specific devices distributed since November 5, 2015. These include both new production devices and recently serviced devices.

Affected products