Medical device manufacturer, Maquet, has issued a medical device alert concerning its Heater-Cooler Unit HCU 40 High Voltage (70104.4054) and Heater-Cooler Unit HCU 40 Low Voltage (70105.4917). All HCU 40 systems below serial number 90442078 are affected.

According to the manufacturer, the vacuum valve in each water circuit is normally closed when the HCU 40 operates. Based on engineering testing, the vacuum valve may not fully close after performing the emptying mode. When the device is operated again, water can leak through the incompletely closed vacuum valve into the inner compartment of the HCU 40.

If the malfunction is not detected prior to use, critical or catastrophic consequences may occur. The manufacturer has not received any complaints of patient harm, serious injuries or deaths.

The manufacturer advises the following to users:

• The manufacturer will replace affected valves within six months.
• Users of HCU 40 systems equipped with the vacuum valve type "Römer" are advised not to use the emptying mode until replacement.
• A replacement unit should be kept on standby to ensure continuous full operation in the event of the vacuum valve leakage.
• If fluid leaks are observed during or after performing any operation modes, the unit should be taken out of operation and repaired by an authorised service technician.

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 action.

Posted on 9 February 2021