It was reported the versatube¿ tapered tracheostomy tube repeatedly deflated in an icu patient.Initial inflation of the cuff demonstrated no obvious tears or leaks, however, the cuff developed leaks 1-2 weeks post insertion each time.The patient was treated with either a tracheostomy tube change or a cap attached to the pilot tube which resolved the cuff leak.The patient required 4 reinsertions of a new size 9 versa tube during icu admission.As reported, the patient was ventilated during the night and on a tracheostomy hood during the day.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.This report references the third occurrence of versa tube deflation.Additional occurrences of tube deflation can be referenced in mfr.Report # 1820334-2019-00497, mfr.Report # 1820334-2019-00499 and mfr.Report # 1820334-2019-00500.Additional information regarding event details and patient outcome has been requested, but is not available at this time.The device from this event was kept and is being sent in for evaluation.
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Investigation/evaluation: a review of the instructions for use and quality control of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.It was concluded that the device in question was visually and functionally inspected by quality control and no related gaps in production or processing controls were noted.The risk specification for this product includes the loss of use failure mode and identifies the risk controls that are in place to mitigate the risk of this type of failure.A review of the device history record could not be completed, as the lot information is unknown.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: warnings: cuff pressure should be monitored and adjusted routinely and should never exceed 25mm hg.Over-inflation of the cuff may inhibit ventilation and may also result in permanent damage to the trachea.Under inflation of the cuff may result in aspiration of subglottic secretions leading to lung infections.Prior to removal of cuffed tracheostomy tubes, ensure that all air is completely removed from the cuff; failing to do so may result in pain to the patient and damage to the trachea and/or stoma.Precautions: for ventilator dependent patients, a replacement tracheostomy tube should be kept at bedside and cuff inflation should be monitored regularly.Instructions for use: tube preparation: test the cuff and inflation system for leakage.With the cuff deflated, taper the cuff back by gently moving away from the distal tip of the outer cannula toward the swivel neck plate as the residual air is removed by deflation.This will ease insertion and guard against cuff perforation by sharp instruments such as forceps or hemostats to taper the cuff; doing so may result in cuff damage.Insertion: inflate the low pressure cuff by injecting air into the luer valve of the inflation line using a syringe.Selection of a cuff inflation and deflation method is at the discretion of the physician/hospital.Based on the information provided, no returned product and the results of our investigation, a definitive root cause could not be established.A quality engineer risk assessment was conducted to assess the risk of this failure mode and concluded no risk reduction activities are required at this time.Cook will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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