Model Number CB004 |
Device Problem
Excess Flow or Over-Infusion (1311)
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Patient Problems
Nausea (1970); Dizziness (2194); Balance Problems (4401)
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Event Date 12/10/2022 |
Event Type
Injury
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Event Description
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Fill volume: 550 ml.Flow rate: 10ml/hr.Procedure: carpal tunnel.Cathplace: unknown.Infusion start time: (b)(6) 2022.Infusion stop time: (b)(6) 2022.A fast flow was reported; the pump infused in 30 hours (date of procedure (b)(6) 2022); the patient experienced nausea and dizziness during infusion.The incident resolved without any medical intervention.Additional information received on 06jan2023 via medwatch/ fda user facility mw report# (b)(4) reported, the dial was set at the appropriate prescribed rate, the clamp was open; all appeared to be visibly intact.
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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 20 jan 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 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 product involved in the report has been returned and is being processed for evaluation.All information reasonably known as of 16 feb 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 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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B5: correction.The actual sample from the reported event was returned for evaluation.The returned product was evaluated and no issues were observed on the device; the complaint cannot be confirmed; therefore, the root cause could not be determined.The device history record for lot 30179495 was reviewed and the product was produced according to product specifications.All information reasonably known as of 03 apr 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 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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Event Description
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It was reported, the patient experienced balance issues; the expected run time [on the pump] was 55 hours.
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Search Alerts/Recalls
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