Important Safety Alerts

Medical device manufacturer, Terumo Cardiovascular Systems (Terumo CVS), has issued a medical device safety alert concerning its CDI H/S Cuvettes.

The manufacturer has received complaints of the CDI System 500 monitor displaying the "H/S DISCONNECT AT CUVETTE" error message when the CDI H/S Cuvette does not make a proper connection to the CDI H/S Probe. In this situation, blood parameter values for HCT, Hgb, and SO2 do not display. The manufacturer has determined that this issue originated from a supplier process related to a component of the CDI H/S Cuvettes, and has taken corrective action. There are no reported injuries as a result of this issue.

If failure of the CDI H/S Cuvette connection is recognized after initiation of cardiopulmonary bypass (CPB), the clinician will have to choose between changing out the cuvette (which requires the interruption of CPB for an indeterminate amount of time) or relying on intermittent discreet blood gas analysis values to trend Hematocrit/Saturation (H/SAT) values (which may be contrary to hospital protocol).

The manufacturer recommends affected users to take the following actions:-

• Upon attachment of the CDI H/S Cuvette to the CDI H/S Probe on the CDI System 500 monitor, verify that a connection is established prior to initiating CPB. This can be confirmed visually on the CDI System 500 monitor by placing the unit in "Operate" mode.
• If the CDI H/S Cuvette does not establish connection to the CDI H/S Probe (as evidenced by the "H/S DISCONNECT AT CUVETTE" error message on the CDI System 500 monitor display), try repositioning the cuvette in the probe head.
• If repositioning the cuvette in the probe head does not result in a successful connection and error-free monitor display, replace the CDI H/S Cuvette using aseptic technique.
• If users experience an "H/S DISCONNECT AT CUVETTE" error message that they are not able to resolve, they should follow their complaint reporting protocol and contact the manufacturer.

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 13 January 2016