Medical device manufacturer, Maquet Cardiopulmonary GmBH, has issued a medical device safety alert concerning its Heater-Cooler Unit HCU 40 [70104.4054 HCU 40 High Voltage, 70105.4917 HCU 40 Low Voltage; with all models and all serial numbers below S/N 90441598].
The manufacturer has received complaints in relation to malfunctions of the HCU 40 flow sensors. A malfunction of the flow sensor causes an error message that prevents further use of the device. The HCU 40 device software supervises the values detected by the flow sensor. A malfunction of the flow sensor generates a signal that is detected by the device firmware as out of range. To prevent further damage or use of a device where the water flow cannot be monitored, the software causes a shut-off of the affected water circuit not allowing desired patient temperature control by this water circuit. Typically, the use of the device is prohibited until the malfunction of the flow sensor is corrected by replacement. However the use of the HCU 40 with only one working water circuit is possible. The manufacturer has not received any complaints associated to serious injuries or deaths due to a malfunction of the flow sensors.
Customers are advised to take the following actions:
Product replacement is on-going
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 29 Nov 2018