It was reported that a portex® bivona® custom tracheostomy tube was narrow and stuff, and the patient experienced respiratory distress.The incident occurred shortly after placement.Air was used to fill the cuff.The patient could not move air and became "dusky" and blue, and was experiencing respiratory distress.The tracheostomy tube was replaced with the one that had just been removed.The patient consulted with their healthcare provider regarding the incident.No permanent injury was reported.
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One portex® bivona® custom tracheostomy tube was returned for investigation.The tracheostomy tube was compared to a similar device and no abnormalities were observed.The device history record was reviewed and no related non-conformities were noted.Since a specific failure mode was not identified in the complaint report, a throughout inspection was performed for every item of the device that could potentially contribute to the reported issue (leak test, dimensional/curvature checks, visual inspection, etc.) and no non-conformities were found.It was noted that the reporter had filed a similar complaint in the past for the same patient, so it is possible there was a patient specific physiological issue that led to this complaint.Additionally, it was noted that the reporter stated they used air to inflate the cuff.Per the device instructions for use, sterile water should be used to inflate the tube.It was determined that the use of air likely would not have led to the specific issue.
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