Catalog Number ALBF040SU |
Device Problem
Device Handling Problem (3265)
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Patient Problems
Cyanosis (1798); Low Oxygen Saturation (2477)
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Event Date 11/28/2023 |
Event Type
Injury
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Manufacturer Narrative
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Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review could not be performed as no lot number was reported.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.
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Event Description
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It was reported that "supreme lma was placed in the pt at the start of the case.It did not seat well and was readjusted with little to no tidal volumes while the surgeon was operating.I required help from the circulating rn to intubate the pt emergently as the supreme lma failed, as it is a rescue device it should not fail.Pt was blue and o2 sats were in the low 60s.Pt was an easy intubation and o2 sats recovered quickly.This is now the second time this week the supreme lmas have failed during a case of mine requiring emergent intubation.Today another anesthesiologist placed a supreme lma that also failed requiring emergent intubation as the pt was blue and hypoxic.So currently, we have had 3 failed rescue devices in 2 days putting pt safety in danger".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.
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Manufacturer Narrative
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Qn#(b)(4).The sample was not returned to the manufacturer.The manufacturer reported: "no actual sample was received for further investigation.Complaint sample received with tracking number was received but the sample was not lma supreme.Product received as lma flexible with a different serial number.Based on the complaint description and review of dhr for the affected lot, there is no abnormalities was identified.There was also no nc raised during the production of the lot.As there was no complaint sample returned to confirm the actual root cause, then the root cause for this complaint is concluded as 'undetermined/unknown'." teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a corrected data: section d.3.Corrected to: teleflex medical athlone wm.
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Event Description
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It was reported that "supreme lma was placed in the pt at the start of the case.It did not seat well and was readjusted with little to no tidal volumes while the surgeon was operating.I required help from the circulating rn to intubate the pt emergently as the supreme lma failed, as it is a rescue device it should not fail.Pt was blue and o2 sats were in the low 60s.Pt was an easy intubation and o2 sats recovered quickly.This is now the second time this week the supreme lmas have failed during a case of mine requiring emergent intubation.Today another anesthesiologist placed a supreme lma that also failed requiring emergent intubation as the pt was blue and hypoxic.So currently, we have had 3 failed rescue devices in 2 days putting pt safety in danger".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.
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Search Alerts/Recalls
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