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

Model Number	220527
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	Numbness (2415)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record for the reported lot number, 30295433, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.The product involved in the report has been returned and is being processed for evaluation.A review of the udi number is in-progress.All information reasonably known as of 22-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 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.
Event or Problem Description
Fill volume: unknown flow rate: unknown procedure: total shoulder cath place: unknown.It was reported the pump dispenses too frequently."pump [was] put in pause mode then turned off.Pump turned back on and program compared to order." it was recommended turning pump off since patient reports numbness increasing but cautioned against letting all numbness resolve.".
Additional Manufacturer Narrative
The device history record for the reported lot number, 30295433, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.One pib-il pump with battery cap and storage cap was received and evaluated.No other components were returned.After cleaning and disinfection, the returned pump was inspected in a well-lit area.There were no visible cracks or breaks on the pump body.There was no visible dried medication or foreign material.The sensor cover was received in position and fully covering the sensor, with no visible damage or debris.There was visible corrosion in the battery compartment and cap.The pump driver did not exhibit cracks, breaks or other damage.Grease was not present around the top of the driver.Batteries were installed, hen turned on, all icons were fully displayed.All history information was retrieved and recorded on the attached form.The pump was received in patient-controlled analgesia (pca) mode.Programming verification was successfully completed.Timing test was performed.A modified cassette was attached to the pump.The pump was placed in run mode.The pump driver could be heard rotating the gears.After three strokes, the pump was paused, and the history was cleared.Timing test was performed.Test result was 20 strokes in elapsed time of 2-minutes, 52-seconds, at which time ¿1¿ was displayed on the screen.Timing test was successfully completed.Simulated use test was attempted using the customer returned pump and a laboratory stock cassette.The "as received" parameters were programmed into the pump.The cassette was attached to the pump and a laboratory medi-bag filled with distilled water.The history was cleared, and the pump was placed in run mode, with calculated test duration of 92-hours.The test began (b)(6) 2025, at 12:15pm.When the run button was pressed, the display sequenced through the rx settings then went to pause.The run button was then pressed again, 0.0 was displayed, followed all icons then went to pause.The run button was then pressed again.0.0 was displayed, then went to pause.The run button was then pressed again, 0.0 was displayed, followed by all icons then pause.After multiple attempts and battery changes, it was not possible to get the pump to run.During the sample evaluation, the pump failed to operate.A pause symbol was observed on the screen, and the pump was not infusing.Root cause could not be determined.All information reasonably known as of 31-oct-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 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.

• Brand Name: AMBIT PIB IL PUMP
• 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: 22570979
• Report Number: 2026095-2025-00018
• Device Sequence Number: 3994508
• Product Code: MEA
• UDI-Device Identifier: 00193494000769
• UDI-Public: (01)00193494000769(240)120002090(11)240403(10)30295433
• Combination Product (Y/N): N
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2025

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: 220527
• Device Catalogue Number: 220527
• Device Lot Number: 30295433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2025
• 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: 06/25/2025
• Supplement Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2024
• 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