Important Safety Alerts

Medical device manufacturer, Terumo BCT, has issued a medical device safety alert concerning its Spectra Optia Apheresis Systems.

The manufacturer has received reports of data entry errors that cause the system to calculate a patient total blood volume (TBV) that is abnormal for that specific patient. The error can occur under the following circumstances:

• The operator accidentally switches the values for height and weight when entering the data.
• The patient is weighed and measured in units that are different from what the operator selects when entering the data.
• The operator enters a height and a weight that are not accurate.

If the operator does not enter correct data, the patient may receive excess anticoagulant (AC) or the outcome of the procedure may be affected. This issue can have the greatest effect on small or compromised patients for whom an abnormally high TBV calculation could lead to hypocalcemia.

The manufacturer instructs affected users to review and confirm the data entered on the systems screens before connecting the patient to the system and throughout the procedure. The manufacturer will also provide software upgrade to mitigate the potential for data entry errors.

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 1 September 2015