MAUDE Adverse Event Report: AVANOS MEDICAL INC HOMEPUMP C-SERIES ELASTOMERIC PUMP, 60 ML, 2 ML/HR (DEHP-FREE); NON-DEHP PUMP - LFR

Model Number	C060020-10
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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).
Event or Problem Description
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 third of three reports.Refer to 2026095-2020-00182 for the first report ; refer to 2026095-2020-00183 for the second report.It was reported that, "several pumps emptied too quickly.".

• Brand Name: HOMEPUMP C-SERIES ELASTOMERIC PUMP, 60 ML, 2 ML/HR (DEHP-FREE)
• Common Device Name: NON-DEHP PUMP - LFR
• Manufacturer (Section D): AVANOS MEDICAL INC; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 11010746
• Report Number: 2026095-2020-00184
• Device Sequence Number: 4496088
• Product Code: MEB
• UDI-Device Identifier: 00193494135577
• UDI-Public: 00193494135577
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K052117
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other,use
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/07/2021
• Device Model Number: C060020-10
• Device Catalogue Number: N/A
• Device Lot Number: 0002983119
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2020
• Initial Report FDA Received Date: 12/15/2020
• Patient Sequence Number: 1