In October, 2015 the US Food and Drug Authority (FDA) issued a circular about the potential risk to patients who had undergone open heart surgery within the last 5 years where a “Sorin” heater-cooler device was used during the surgery. This circular suggests that the heater-cooler device has been linked to a life threatening bacterial infection which could have been passed from the device to the patient. All Irish Hospitals where open heart surgery is conducted, with the use of this device have been advised to notify the potentially affected patients.
According to the FDA report which singled out the “Sorin” device, it states that the device may have been contaminated during the manufacturing process which would mean that certain lots of the device used by Hospitals around the world may contain the bacteria Mycobacteria Chimera. We are aware of Irish cases where the device was used.
Mycobacteria Chimera is a group of common slow growing environmental organisms which can cause respiratory infections or severe disease particularly in people whose immune systems are compromised. This bacteria is linked to “endocarditis”, which can be fatal. The signs and symptoms of endocarditis are;
Fever and chills.
A new or changed heart murmur.
Aching joints and muscles.
Profuse night sweats.
Shortness of breath.
Swelling in feet, legs or abdomen.
Blood in the urine.
Pain in the stomach.
Red tender spots under the skin of the fingers.
There is litigation on a global scale in relation to “Sorin” products. If you have had open heart surgery within the last five years and have suffered from any of the above signs and symptoms then you may well be one of the patients who was subjected to the defective heater-cooler device products.
If you have any queries, please contact us at Cantillons, Solicitors at 021 4275673 or [email protected]
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