AVANOS MEDICAL - IRVINE HOMEPUMP C-SERIES, 270 ML, 5 ML/HR (CONTAINS DEHP); ELASTOMERIC LFR
|
Back to Search Results |
|
Model Number C270050 |
Device Problem
Excess Flow or Over-Infusion (1311)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
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 10-dec-2018 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).
|
|
Event Description
|
Avanos medical received a single report that referenced three different incidents, which were associated with separate units, involving an unknown number of patients.This is the third of three reports.Refer to 2026095-2018-00156 for the first event.Refer to 2026095-2018-00158 for the second event.Fill volume: unknown, flow rate: unknown, procedure: unknown, cathplace: unknown, it was reported that a clinic has been experiencing a fast flow issue associated with the use of an elastomeric pump.No patient injury reported.
|
|
Search Alerts/Recalls
|
|
|