Heater-Cooler Unit HCU 40 (2018-11-26)

Starting date:

November 26, 2018

Posting date:

January 9, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-68638

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  Reason
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  Affected products

Affected products

Heater-Cooler Unit HCU 40

Reason

The HCU 40 system comprises two separate water circuits with temperature regulation. The first circuit is for connecting the oxygenator heat exchanger and/or the warming/cooling blanket, the second circuit is intended for connecting the cardioplegia heat exchanger. Both water circuits of the HCU 40 contain a flow sensor which measures the water flow to ensure an adequate flow from the device to the connected accessories.  Maquet Cardiopulmonary GmbH 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.

Maquet Cardiopulmonary has not received any complaints associated to serious injuries or deaths due to a malfunction of the flow sensors.

Affected products