The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom (UK) posted a medical device safety alert concerning SYNERGY Circulatory Support System, manufactured by CircuLite GmbH. The affected device is SYNERGY Micro-Pump Kit SIK 100 (Note: This kit is also part of the SYNERGY Implantation Kit SIK 001).
According to the alert, CircuLite is now evaluating the root causes of inflow cannula fracture after receiving three relevant reports. Effective immediately, CircuLite is suspending implants of the surgical SYNERGY Circulatory Support System in Europe until further notice.
The manufacturer provides the following advice to the affected users:
- Physicians are advised to suspend implant of the SYNERGY system in new patients.
- Physicians are advised to inform patients of this safety alert.
- Patients currently on device should be monitored as usual for any signs of low flow through the pump in the absence of a decrease in speed setting during routine follow-up exams (e.g., decreased current, hemolysis).
- If low flow is suspected, obtain a chest x-ray and/or CT scan to evaluate the inflow cannula position and integrity.
- If a cannula fracture is suspected, the pump should be stopped under medical supervision and a decision made as to whether or not to explant the pump.
- A decision should be made as to whether the patient requires support with another form of mechanical circulatory support or can be managed medically. If the pump is explanted, blood should be aspirated from the inflow cannula and outflow graft to extract any thrombus that may have formed during the period of pump stop. The outflow graft can be ligated near its insertion with the subclavian artery. The inflow cannula can be occluded using a vascular occlusion device.
- As usual, patients should be instructed to return to the hospital for controller alarms or if they exhibit signs of hemolysis such as red tinged or dark colored urine.
- Existing patients will continue to be supported. At this time, devices that are serving as backup for patients who were previously implanted may be retained. Unnecessary devices should be returned to the manufacturer.
- Immediately inform CircuLite if any abnormalities in the pump or patient are observed.
For details, please visit the following MHRA website:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON297539
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 7 August 2013