The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 11-jul-2023 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical, inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical, inc.Avanos medical, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical, inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical, inc.Product is defective or caused serious injury.H3 other text : device not returned.
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Avanos medical received a single report that referenced seven different incidences, which were associated with separate units, involving seven different events.This is the fifth of seven reports.Refer to 2026095-2023-00070 for the first event.Refer to 2026095-2023-00071 for the second event.Refer to 2026095-2023-00072 for the three event.Refer to 2026095-2023-00073 for the fourth event.Refer to 2026095-2023-00075 for the sixth event.Refer to 2026095-2023-00076 for the seventh event.Fill volume: unknown.Flow rate: unknown.Procedure: unknown.Cathplace: unknown.It was reported the pump infused faster than the 46-hour timepoint, and when the pump runs fast the patient experiences flushing as a side effect.There was no reported injury or medical intervention.
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