translation missing: ko.activerecord.attributes.event.titles.recall_field_safety_notice

Recall / Field Safety Notice

mdprc 090 11 18 000

2018-11-27

Saudi Arabia

SFDA

https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=13539

The hcu 40 heater-cooler unit is intended for cooling and warming a patient connected to the extracorporeal perfusion circuit and maintaining the patient temperature at the required level during cardiovascular interventions. the 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.