MAUDE Adverse Event Report: AVANOS MEDICAL INC. AMBIT ELECTRONIC PAIN CONTROL PUMPS; ELECTRONIC INFUSION PUMPS & SYSTEMS

Model Number	220527
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	Unspecified Nervous System Problem (4426)
Date of Event	04/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record and udi are in-progress.All information reasonably known as of 18 may 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
Avanos medical inc.Received a single report that referenced two different incidents, which were associated with separate units, involving the same (one) patient.This is the second of two reports.Refer to 2026095-2026-00041 for the first report the customer reported that following ankle surgery performed on (b)(6) 2026, a patient was discharged with an ambit infusion pump connected to a catheter site for postoperative local anesthetic infusion therapy.The patient later reported that approximately 300 ml of local anesthetic had infused within approximately 12 hours and subsequently became symptomatic, possibly consistent with local anesthetic systemic toxicity (last).Emergency medical services (ems) were contacted, and the catheter was removed in the field.The patient was not admitted to the hospital.Additional information was received on 24-apr-2026, reporting that the programmed settings for the pump were: initial loading dose 12 ml, dose 6 ml, interval 2 hours, bolus 3 ml, lockout time 30 minutes, and 500 ml medication bag.The reporting physician indicated the patient may have misinterpreted the pump display rather than an actual over-infusion occurring.

• Brand Name: AMBIT ELECTRONIC PAIN CONTROL PUMPS
• Common Device Name: ELECTRONIC INFUSION PUMPS & SYSTEMS
• 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
• Manufacturer Contact: tamara cardona ; 5405 windward parkway; alpharetta, GA 30004 ; +1(470)448-5487
• MDR Report Key: 25209048
• Report Number: 2026095-2026-00044
• Device Sequence Number: 8981831
• Product Code: FRN
• UDI-Device Identifier: 00193494000769
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K162165
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2026

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: 220527
• Device Catalogue Number: 220527
• Device Lot Number: 20130525
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2026
• Supplement Date Received by Manufacturer: 07/17/2026
• Initial Report FDA Received Date: 05/18/2026
• Supplement Report FDA Received Date: 08/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/06/2025
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Age: 68 YR
• Patient Sex: Female