MAUDE Adverse Event Report: AVANOS MEDICAL INC. HOMEPUMP C-SERIES; ELASTOMERIC LFR

Model Number	C100020
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record for lot 30333138 was reviewed and the product was produced according to product specifications.The actual complaint product was not returned for evaluation.Root cause could not be determined.All information reasonably known as of 09 jun 2026 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 reported event but is relaying the information 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).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 or Problem Description
The customer reported a fast flow condition involving an elastomeric infusion pump used to administer fluorouracil as part of a folfox protocol.The infusion pump was intended to deliver therapy over 46 hours; however, the patient returned approximately three hours earlier than expected and the pump was already empty.No signs of drug extravasation were reported.No patient injury or medical intervention was reported.

• Brand Name: HOMEPUMP C-SERIES
• Common Device Name: ELASTOMERIC 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.
• Manufacturer Contact: tamara cardona ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 25448994
• Report Number: 2026095-2026-00050
• Device Sequence Number: 15830249
• Product Code: MEB
• UDI-Device Identifier: 00193494135614
• UDI-Public: (01)00193494135614(240)120007059(11)240826(17)270224(10)30333138
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K052117
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2026

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: Lay User/Patient
• Device Model Number: C100020
• Device Catalogue Number: C100020
• Device Lot Number: 30333138
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2026
• Supplement Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 06/09/2026
• Supplement Report FDA Received Date: 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FLUOROURACIL
• Patient Sex: Unknown