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

Model Number	220546
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported via fda medwatch medsun report (b)(4), ¿the (rn) set up an ambit peripheral nerve catheter pump for a patient.The pump was programmed to deliver an intermittent bolus of 8ml every 2 hours.However, after the initial bolus was started, the pump malfunctioned and was about to administer more than the intended dose.The rn quickly disconnected the pump from the patient's catheter and observed that it had reached 9.6ml before turning it off.The rn then discussed the issue with the primary medical team and was instructed to use existing orders and obtain a new ambit pump.The initial 8ml bolus was wasted to ensure that the patient does not receive a double dose of medication.Therapies being used on the patient at the time of the event that may have caused or contributed to the event: not known;¿ the incident occurred in may 2024.
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record is not possible as a valid lot number was not provided; therefore, the udi-pi is unavailable.A root cause could not be determined.All information reasonably known as of 16 oct 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 (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
The device history record for lot 30265969 was reviewed and the product was produced according to product specifications.All information reasonably known as of 14 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: AMBIT
• 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.
• Manufacturer Contact: tamara cardona ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 20464324
• Report Number: 2026095-2024-00055
• Device Sequence Number: 8855433
• Product Code: MEA
• UDI-Device Identifier: 00193494001308
• UDI-Public: (01)00193494001308(240)120004052(17)260313(10)30265969
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2025

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: Health Professional
• Device Model Number: 220546
• Device Catalogue Number: 220546
• Device Lot Number: 30265969
• Was Device Available for Evaluation?: No
• 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: 09/26/2024
• Supplement Date Received by Manufacturer: 06/15/2025
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/23/2023
• 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 Sex: Unknown