MAUDE Adverse Event Report: AVANOS MEDICAL INC. HOMEPUMP C-SERIES, 125 ML, 5 ML/HR (CONTAINS DEHP); ELASTOMERIC LFR

Model Number	C125050
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Avanos medical received a single report that referenced two different incidences, which were associated with separate units, involving two different events.This is the second of two reports.Refer to 2026095-2024-00066 for the first event.Fill volume: 65 ml.Flow rate: 5 ml/hr.Procedure: unknown.Cathplace: unknown."pump infused at significantly higher rate than 5 ml per hour.1300 mg lidocaine 2% (65 ml) infused over 7-8 hours risking precipitous side effects.Patient unharmed." the room temperature was (22°c / 72°f).The pump was below the catheter, four inches (distance between the pump and catheter.The tubing was under the patient's clothing and/or blanket.About 20-minutes elapsed between filling the pump and starting the infusion.
Additional Manufacturer Narrative
The actual device is reported to be available but has not been returned for evaluation.A review of the device history record and udi number are in-progress.All information reasonably known as of 25-nov-2024 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 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, inc.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.
Additional Manufacturer Narrative
Additional information: d9, h3, h6 the product involved in the report has been returned and the investigation remains in progress at this time.All information reasonably known as of 23 dec 2024 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 comp- (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.
Additional Manufacturer Narrative
Additional information: d4, h4, h6, h11.The device history record for lot 30251124 was reviewed and the product was produced according to product specifications.The actual complaint product was returned for evaluation.Pressure pot was performed on the flow restrictor, and yielded within specifications, no fast flow was observed.A root cause could not be determined.All information reasonably known as of 25 feb 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, 125 ML, 5 ML/HR (CONTAINS DEHP)
• 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: 20799438
• Report Number: 2026095-2024-00067
• Device Sequence Number: 6754916
• Product Code: MEB
• UDI-Device Identifier: 00193494135638
• UDI-Public: (01)00193494135638(240)101356305(17)251025(10)30251124
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/26/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/25/2025
• Device Model Number: C125050
• Device Catalogue Number: C125050
• Device Lot Number: 30251124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/30/2024
• Supplement Date Received by Manufacturer: 12/03/2024; 02/18/2025
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 12/26/2024; 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2023
• 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: LIDOCAINE 2%.
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 65 KG