VYAIRE MEDICAL OY MEDISORB¿ MULTI-ABSORBER ORIGINAL, DISPOSABLE; ABSORBENT, CARBON-DIOXIDE
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Model Number MEDISORB, MULTI ABSORBER CANISTER |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/11/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Vyaire medical file identification:(b)(4) h3: 81 other - at this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
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Event Description
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It was reported to vyaire medical that the 8003138 medisorb, multi absorber canister was found leaking.At this time, there is no information regarding patient involvement associated with the reported event.
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Manufacturer Narrative
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H10.Additional mfr narrative/corrected device evaluation update: g3, g6, h2, h3, h6 and h10 results of investigation: vyaire medical was able to verify the reported issue.The production records revealed no deviations from the device's specifications throughout manufacture.All packed products passed a 100% leak test and visual inspection.A review of the batch documentation for lot l01a-01381 revealed no problems that could be attributed to damage.The returned sample was visually inspected, and leak tested; multiple cracks were discovered at the canister's top, indicating that the canister was subjected to significant force during transportation following the 100% in line leak and visual inspection check in the manufacturing line.Vyaire has investigated broken canisters reported by customers and vyaire has implemented adjustment to the packaging and these modifications are currently ongoing.
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Search Alerts/Recalls
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