(b)(4).The product involved in the report has been returned and is being processed for evaluation.A review of the device history record is in-progress.All information reasonably known as of 19-mar-2020 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.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).
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Fill volume: 201ml.Flow rate: 2ml/hr.Procedure: chemotherap.Cathplace: unknown.It was reported a pump set at 2 ml/hr for 96-hours but the device infused over about 48 hours.The pump was intended to be initiated on monday and removed on friday.The patient reported to the clinic on thursday afternoon stating that the pump was completely empty sometime wednesday night.The patient experienced symptoms of "fast flow" and the clinic treated the pateint with "hydration".Additional information received 24-feb-2020 noted the pharmacist stated the patient experienced "neurologic symptoms," nausea, mouth sores and fatigue.The patient returned today for hydration and will continue to be monitored until the next chemotherapy cycle which is due on b)(6) 2020.
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The device history record for the reported lot number, 0002963600, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.One sample device was received empty.The device was evaluated for flow and pressure and testing.The evaluation concluded the device was within specifications.The failure was not confirmed.A root cause was not identified.All information reasonably known as of 26-may-2020 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.
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