MAUDE Adverse Event Report: AVANOS MEDICAL INC. HOMEPUMP C-SERIES, 270 ML, 5 ML/HR; ELASTOMERIC LFR

Model Number	C270050
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record for lot 20119996 was reviewed and the product was produced according to product specifications.The product involved in the report has been returned and the investigation remains in progress at this time.All information reasonably known as of 06 jan 2025 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
Fill volume: 241 ml.Flow rate: 5 ml/hr.Procedure: unknown.Cathplace: unknown.Infusion start time: (b)(6) 2024 at 1340.Infusion stop time: (b)(6) 2024 at 1522.It was reported, ¿patient reported he believed an avanos c270050 lot 20119996 exp 09/24/2026 pump was running too fast due to wrinkling and weight of the bag.It was his 49th cycle so he is familiar with the product.¿ it was additionally reported ¿patient called (b)(6) 2024 15:22 reporting he believed pump was running faster than it should.He reported it was more wrinkled and lighter than usual.Patient is on his 49th cycle so he is familiar with the drug.Visually writer (rph) and infusion nurses could not tell.Phone call documentation ¿call transferred to writer by care access - patient left dng med on clinic with 5fu pump - he reports that pump appears to be emptying quicker than previous cycles.Inner bulb of 5fu pump is still firm per patient but bulb has seemed to already decrease in size noted by outer layer of pump.Patient denies any new/adverse symptoms at this time.Instructed patient to clamp 5fu pump - and will proceed to dng clinic for rn assessment of pump.Patient verbalized understanding - schedule coordinated.Infusion rn's updated.The pump was remade and follow up pump ran normally using same model and lot number.¿.
Additional Manufacturer Narrative
The device history record for lot 20119996 was reviewed and the product was produced according to product specifications.The actual complaint product was returned for evaluation.The pump was received filled, it was drained and refilled, flow accuracy test was performed, and it yielded within specifications.Pressure pot testing was performed on the flow restrictor, and it yielded below specifications, an occlusion was detected at the end of the glass orifice.The occlusion could be caused due to the pump being filled with the medicine for a longer period; therefore, the fast flow incident was not confirmed.A root cause could not be determined.All information reasonably known as of 08 jul 2025 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.

• Brand Name: HOMEPUMP C-SERIES, 270 ML, 5 ML/HR
• 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: 21085157
• Report Number: 2026095-2025-00001
• Device Sequence Number: 20929345
• Product Code: MEB
• UDI-Device Identifier: 00193494135683
• UDI-Public: (01)00193494135683(240)101356805(17)260924(10)20119996
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2025

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 Expiration Date: 09/04/2026
• Device Model Number: C270050
• Device Catalogue Number: C270050
• Device Lot Number: 20119996
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2024
• 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: 12/13/2024
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2024
• 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: 5FU FRESENIUS KABI.; ICU MEDICAL NORMAL SALINE.
• Patient Age: 61 YR
• Patient Sex: Unknown