Fill volume: 550 ml.Flow rate: 10 ml/hr.Procedure: left knee total replacement.Cathplace: left knee regional block.Date of procedure: (b)(6) 2021.Infusion start time: unknown.Infusion stop time: unknown.It was reported that the pump was experiencing a fast flow issue after a total knee procedure.It was also reported that the patient experienced weakness, numbness, and tingling as a result of the pump infusing too quickly.Additional information received 29-sep-2021 stated doing well and side effects subsided.
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The device history record for the reported lot number, 80401040, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.All information reasonably known as of 10-dec-2021 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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