The UK Medicines and Healthcare products Regulatory Agency (MHRA) issued a Field Safety Notice to alert healthcare providers and customers regarding the Freedom Driver System manufactured by SynCardia Systems, Inc.
According to the manufacturer, a Freedom Driver supporting a patient in the United States exhibited intermittent low cardiac output alarms as a result of instances of elevated systolic blood pressure readings above 160mmHg. While all distributed Freedom Drivers are within specifications, some can support a higher level of transient instances of hypertension than others. The Driver that is the subject of the event was less tolerant to these elevated pressures, resulting in the low CO alarms.
SynCardia is replacing Freedom Drivers that are less tolerant of these types of events with Drivers that are more tolerant of these types of elevated systolic pressures.
For details, please refer to the following MHRA website:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/index.htm
If you are in possession of the affected products, please stop using them and contact your supplier for necessary actions.