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Model Number CB003 |
Device Problem
Physical Resistance/Sticking (4012)
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Patient Problem
Insufficient Information (4580)
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Event Date 08/17/2023 |
Event Type
malfunction
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Event Description
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Avanos medical received a single report that referenced three different incidences, which were associated with separate units, involving three different events.This is the first of three reports.Refer to 2026095-2023-00095 for the second event.Refer to 2026095-2023-00096 for the third event.Fill volume: unknown.Flow rate: unknown.Procedure: unknown.Cathplace: unknown.It was reported the "on-demand button did not reset and remained in the down position." there was no reported injury.
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Manufacturer Narrative
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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 06-sep-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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Manufacturer Narrative
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Additional information: b3, b5 and d10.All information reasonably known as of 06-oct-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 06-sep-2023 stating the "bolus button remained depressed for 39 minutes.Decision made to discontinue on q pump and have patient use an ambit pump.No patient harm reported.No signs and symptoms of lidocaine toxicity reported.".
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Manufacturer Narrative
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All information reasonably known as of 14-nov-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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Search Alerts/Recalls
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