Catalog Number 100/800/080 |
Device Problem
Material Rupture (1546)
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Patient Problems
Death (1802); Pneumothorax (2012); Ventricular Fibrillation (2130); Ventricular Tachycardia (2132); Ulcer (2274)
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Event Date 07/06/2017 |
Event Type
Death
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Event Description
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It was reported that the patient expired after a malfunction of a portex® cuffed blue line ultra® tracheostomy tube.It was reported that the patient sustained a tracheal injury by "explosion" of the cuff.While attempting to perform a cannula replacement, "bulging" was observed and it was necessary to change the tracheostomy tube twice.It was observed that the patient experienced a tracheal lesion due to the cuff, followed by bilateral pneumothorax, hemodynamic instability, and "non-reversed pcr".
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Manufacturer Narrative
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Reporter provided new device information.
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Event Description
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Patient required cpr for 40 minutes and was moved to electrical cardioversion and prescribed amiodarone when patient went into ventricular fibrilation and tachycardia.Cpr was restarted and patient passed away 7 minutes later.
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Manufacturer Narrative
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Two devices were returned for evaluation in used condition and without their original packaging.Visual inspection found one of the samples had a hole in the cuff and the other sample had a herniation.A review of the testing and inspection documents was performed and deemed adequate and correct.A review of the manufacturing process was performed on a similar part and found no discrepancies or anomalies.A sample of 32 devices underwent leak testing and did not identify any deflated or deformed cuffs.A review of the instructions for use was performed.Based on the evidence, a root cause was unable to be determined.
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Search Alerts/Recalls
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