CDI BLOOD PARAMETER MONITORING SYSTEM 500 - MONITOR WITH BLOOD PARAMETER MODULES AND ONE HCT/SAT PROBE (2015-08-25)

Starting date:

August 25, 2015

Posting date:

September 24, 2015

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-55004

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  Reason
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  Affected products

Affected Products

A. CDI BLOOD PARAMETER MONITORING SYSTEM 500 - MONITOR WITH ONE BLOOD PARAMETER MODULE AND ONE HCT/SAT PROBE

B. CDI BLOOD PARAMETER MONITORING SYSTEM 500 - MONITOR WITH TWO BLOOD PARAMETER MODULES AND ONE HCT/SAT PROBE

Reason

Terumo Cardiovascular Systems (Terumo CVS) has determined that changes made when upgrading CDI system 500 software from version 1.65 to version 1.69 were not expected or fully understood by users, and that the following user instructions need to be clarified: In-vivo calibration: measured values prior to initial in-vivo calibration may not be used for patient management. at the beginning of a case, you must complete calibration of all measurable blood parameters by comparing them to a laboratory measurement done on a blood sample. The values are dimmed on the CDI system 500 screen to indicate that the values are not accurate until an initial in-vivo calibration is performed.Operating ranges: if a lab measured value is outside the operating range for a parameter, you may not be able to adjust the CDI system 500 measured values to the lab measured value. Accuracy has not been established for displayed values outside the operating range. Therefore, displayed values outside the operating range should not be used for patient management. While this condition exists, continue patient management with another source (i.e., laboratory or point-of-care blood gas analyzer). See CDI system 500 operating ranges: reference table for system accuracy limits.Temperature: the temperature measured by the shunt sensor is local to the sensor and does not reflect the actual patient arterial temperature. Do not use this measurement for patient management.

Affected products