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

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.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 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)
• Type of Device: NON-DEHP PUMP - LFR
• Manufacturer (Section D): AVANOS MEDICAL INC; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT S. DE R.L. DE C.V.; ave noruega edificio d-1b; fraccionamiento rubio; tijuana b.c. 22116 ; MX 22116
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 11010746
• MDR Text Key: 221839679
• Report Number: 2026095-2020-00184
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00193494135577
• UDI-Public: 00193494135577
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K052117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 11/26/2020
• Initial Date FDA Received: 12/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1