Model Number UNKNOWN |
Device Problem
Improper Flow or Infusion (2954)
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Patient Problem
Insufficient Information (4580)
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Event Type
malfunction
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Event Description
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Avanos medical inc.Received a single report that referenced multiple incidences, which were associated with separate units, involving multiple patients.The exact quantity is unknown at this time.This is the second of three reports.Refer to 2026095-2023-00109 for the first report refer to 2026095-2023-00112 for the third report.Fill volume: unknown ml.Flow rate: 2 ml/hr.Procedure: unknown.Cathplace: unknown.Infusion start time: unknown.Infusion stop time: unknown.It was reported, the facility has had patients who have been receiving 5-fluorouracil (5-fu) through the avanos c-series pumps but are stating the pumps empty out before the disconnect appointment (at roughly 41 hours).No injury or medical interventions reported.
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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.A root cause is undetermined.All information reasonably known as of 21 dec 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 reported event but is relaying the information 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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No product failure occurred.No further information will be submitted regarding this report 2026095-2023-00110.All information reasonably known as of 22 jan 2024 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 reported event but is relaying the information 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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Per additional information received on 05jan2024, "the patient may have been mistaken and thought the pump was empty when it wasn't." no product failure occurred.
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Search Alerts/Recalls
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