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Model Number C100020 |
Device Problem
Excess Flow or Over-Infusion (1311)
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Patient Problems
Abdominal Pain (1685); Malaise (2359); Insufficient Information (4580)
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Event Type
Injury
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Manufacturer Narrative
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The device history record for the reported lot number, 30161091, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.The actual complaint product was not returned for evaluation.All information reasonably known as of (b)(6) 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, 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.H3 other text : the device was not returned.
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Event Description
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Avanos medical received a single report that referenced four different incidences, which were associated with separate units, involving four different events.This is the fourth of four reports.Refer to 2026095-2023-00008 for the first event.Refer to 2026095-2023-00009 for the second event.Refer to 2026095-2023-00010 for the third event.Fill volume: 96 ml/hr, flow rate: 2 ml/hr, procedure: unknown, cathplace: unknown, start time (b)(6) 2022 at 1415 , end time 21-dec-2022 at 0000.It was reported the patient experienced a rapid infusion during use.The device infused in 33-hours and 45-minutes instead of 48-hours. there was an unspecified reported injury, and no medical intervention was required.
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Manufacturer Narrative
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All information reasonably known as of 15-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, 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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Event Description
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Additional information received 18-jan-2023 stating the patient experienced general malaise and abdominal pain.The patient was to receive "clinical support and medications, if necessary, in case of continuity of symptoms." the patient was reported to be stable.
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Search Alerts/Recalls
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