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 13-dec-2018 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).
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Fill volume: unknown.Flow rate: unknown.Procedure: unknown.Cathplace: unknown.It was reported that a patient's elastomeric pump ran out a day and a half too soon.The reason for the early completion could not be identified.It was noted that the correct amount of drug was added to the pump.The patient liked to keep the pump in the breast pocket of his shirt, so it was thought that might have contributed to the event but was not enough to run out that quickly.The patient also confirmed he was not in a warm environment.Additional information received on 05-dec-2018 stated that the staff was certain the volume was correct, and feels that this is a patient issue.No patient injury reported.
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