Catalog Number 100/860/080 |
Device Problems
Air Leak (1008); Material Deformation (2976); Torn Material (3024)
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Patient Problem
Apnea (1720)
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Event Date 04/19/2017 |
Event Type
Injury
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Manufacturer Narrative
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Smiths medical has received the sample device.A full evaluation is anticipated, but not yet begun, as the device is currently in transit to the invesitgation site.
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Event Description
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It was reported that a portex® cuffed blue line ultra® suctionaid tracheostomy tube had a leak.During a regular patrol, the nurse found that the patient's thorax did not move and went into respiratory arrest.A section was attempted, but the suction catheter couldn't be inserted due to the amount of secretion.The tracheostomy tube was then replaced.When checking the tracheostomy tube, it was noted that the cuff experienced an air leak.It was also observed that the cuff was largely torn and there was a "deformation" (one-sided inflation).The device was tested according to the instructions for use prior to insertion.The patient was resuscitated after the respiratory arrest.No permanent injury was reported, and the outcome of the event was reported to be full resolution.
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Manufacturer Narrative
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One device was returned for evaluation in used condition and without its original packaging.Visual inspection of the device found that there was a hole in the cuff.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.A review of the inflation test was performed on 32 devices and found no deflated cuffs.Based on the evidence, the complaint was observed and a root cause was unable to be determined.
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Search Alerts/Recalls
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