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The Sorin Group Italia have issued a Field Safety Corrective Action Notice concerning a number of complaints received from its customers regarding a leak between the blood and water compartments of the heat exchanger in a number of its oxygenators. The reported occurrence rate is very low, < 0.002%. Investigations suggest that the leaks may be caused by prolonged contact with sodium chloride (NaCl), causing micro holes to appear in the heat exchanger.
The Safety Committee would like to make the UK community aware of this situation and suggest that the instructions be followed in the attached document.
