Model Number UNKNOWN |
Device Problem
Infusion or Flow Problem (2964)
|
Patient Problem
Insufficient Information (4580)
|
Event Type
malfunction
|
Manufacturer Narrative
|
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 (b)(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.
|
|
Event Description
|
Avanos medical received a single report that referenced three different incidences, which were associated with separate units, involving three different events.This is the second of three reports.Refer to 2026095-2023-00029 for the first event.Refer to 2026095-2023-00031 for the third event.It was reported there were "some issues with their pump (completing treatment earlier than expected)." there was no reported injuries.
|
|
Event Description
|
Additional information received 23-mar-2023 noting one pump was affected and the fill volume is usually 545cc and the user was unable to confirm whether the pump was filled to the correct volume or not.
|
|
Manufacturer Narrative
|
All information reasonably known as of 19-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, 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.
|
|
Search Alerts/Recalls
|
|