AVANOS MEDICAL INC. HOMEPUMP ECLIPSE ELASTOMERIC PUMP, 400 ML, 100 ML/HR (DEHP-FREE); NON-DEHP PUMP - HFR
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Model Number E401000-10 |
Device Problem
Excess Flow or Over-Infusion (1311)
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Patient Problem
Tachycardia (2095)
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Event Type
malfunction
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Event Description
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Fill volume: 350ml.Flow rate: unknown.Procedure: unknown.Cathplace: unknown.Infusion start time: unknown.Infusion stop time: unknown.It was reported that the pump diffused in 1 hour 30 minutes instead of 3 hours.The product administered as 1g solumedrol in 350ml of 0.9% saline.No further information was provided.Per additional information received, "following the more rapid diffusion of corticosteroids, the patient had a slight tachycardia which faded spontaneously.Afebrile throughout his corticosteroid treatment.".
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Manufacturer Narrative
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The sample is reported to be available, but has not yet been received by the manufacturer.A review of the device history record is in-progress.All information reasonably known as of 07 feb 2022 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 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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Manufacturer Narrative
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One used device was returned for evaluation.Testing of the pump by refilling it with saline revealed flow rates that were within specification.No fast flow was observed.The complaint could not be confirmed as reported.Root cause was not determined.All information reasonably known as of 15 mar 2022 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 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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Manufacturer Narrative
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The device history record for lot 80400720 was reviewed and the product was produced according to product specifications.All information reasonably known as of 23 feb 2022 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 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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