Model Number FLOW-I C20 |
Device Problem
Contamination /Decontamination Problem (2895)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/17/2021 |
Event Type
malfunction
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Event Description
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It was reported that the sevoflurane vaporizer had a yellow residue on the inside.The vaporizer is the unit containing anesthetic agent in the anesthesia workstation.There was no patient harm.Manufacturer´s ref.# (b)(4).
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Manufacturer Narrative
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The investigation has been completed.The vaporizer was returned for investigation and the reported issue was confirmed.The yellow residue inside the vaporizer has been analyzed in a chemical analyze and the cause of the yellow residue is due to degradation of sevoflurane creating hydrogen fluoride.The concerned vaporizers are sevoflurane with maquet fill and safe-t-seal (which is keyed to sevoflurane from baxter).A root cause analysis has been performed regarding the formation of hydrogen fluoride within sevoflurane vaporizers.The root cause analysis found that changes in design and manufacturing process introduced in 2018 was the reason for the formation of hydrogen fluoride.The main reason for the manufacturing change in 2018 was to facilitate easier assembling in production and to get a better sourcing of certain components.The surface treatment in the aluminum canister that form the main part of the liquid container in the vaporizer was found to be inadequate.To prevent this from happening the sevoflurane vaporizer will be redesigned.The fsca has been initiated to remove all the concerned vaporizers from the field.The removing of the concerned vaporizers are to be completed until 2023-04-01.
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Event Description
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Manufacturer's reference #: (b)(4).
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Search Alerts/Recalls
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