The customer reported that at the first postoperative day, the tube has collapsed, rendering it ineffective and posing a life-threatening situation for the patient.The chest tube was seriously kinked intrathoracic and non functional (photo).During the thoracic procedure, they developed serious subcutaneous emphysema at early postoperative time.The patient had serious complications and prolonged hospitalization.
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A photo sample was received for the investigation.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Upon a visual evaluation of the photo sample, the reported issue was confirmed; the tubing was kinked.A root cause analysis indicated that this occurred due to user error.If a physical sample is received at a later date, this complaint will be reopened for further investigation.
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