AVANOS MEDICAL INC. HOMEPUMP C-SERIES ELASTOMERIC PUMP, 60 ML, 2 ML/HR (DEHP-FREE); NON-DEHP PUMP - LFR
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Model Number C060020-10 |
Device Problem
Excess Flow or Over-Infusion (1311)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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The actual complaint product was not returned for evaluation.Root cause could not be determined.The device history record for lot#: 0002983119 was reviewed, and the product was produced according to product specifications.All information reasonably known as of 11 dec 2020 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.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 complaint database and identified as complaint (b)(4).
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Event Description
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Avanos medical inc.Received a single report that referenced three different incidences, which were associated with separate units, involving an unknown number of patients.This is the second of three reports.Refer to 2026095-2020-00182 for the first report ; refer to 2026095-2020-00184 for the third report.It was reported that ,"several pumps emptied too quickly.".
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Search Alerts/Recalls
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