Medical device manufacturer, Tem Innovations GmbH, has issued a medical device safety alert concerning its ROTEM ex-tem [Part Number: 503-05; Lot Number: 42255701; Expiry Date: 31 March 2020].

The manufacturer has received customer complaints on the affected lot of ROTEM ex-tem, reporting prolonged clotting times (CT) with multiple lots of ROTROL N controls.

According to the manufacturer, its internal testing has also demonstrated prolonged ex-tem CT results outside of the normal range for healthy donor whole blood samples. This could potentially result in patients being inappropriately transfused with fresh frozen plasma or prothrombin complex concentrate. It is predicted to have temporary or reversible health/ safety consequences to patient.

To date, there have been no reports of erroneous patient results.

The customers are required to take the following immediate actions:

• Check their inventory for the affected product [Lot Number: 42255701] and destroy all remaining material.
• Document the destruction and contact the manufacturer's local representative for an alternative product lot of the affected product.
• Share the information of Field Safety Notice (FSN) with their laboratory staff and follow their internal procedure.
• Forward the FSN to all affected locations within their facility.

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 26 July 2019