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

Model Number	220571
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Fill volume: 500 ml.Flow rate: 8ml/hr, bolus 6ml every 20 min.Procedure: anterior cruciate ligament/medial collateral ligament (acl/mcl) repair.Cathplace: unknown.Infusion start time: (b)(6) 2023.Infusion stop time: (b)(6) 2023.It was reported, the ambit pump ¿seemed to run out of meds early friday morning¿.¿ambit ran out at 5am on 24th-had only pushed button 2x for extra meds¿.During a phone call the patient stated, ¿the pump infused too quickly but i am not really sure.I guess that was how the doctor programmed the pump.I just expected the pump to last longer¿.She reported, she believed the pump was started around 5pm the day of her surgery on (b)(6) 2023.The patient denied experiencing any adverse side effects: no dizziness, ringing of ears, blurred vision, metallic taste in mouth, etc.There was no reported injury.
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.A review of the device history record is in-progress.All information reasonably known as of 1=(b)(6).2023 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 complaint database and identified as (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 f113204 was reviewed and the product was produced according to product specifications.The returned product was evaluated and no issues were observed on device.The root cause could not be determined since the reported failure was not reproduced in lab during sample evaluation.All information reasonably known as of (b)(6) 2023 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 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 ELECTRONIC PAIN CONTROL PUMP
• Common Device Name: ELECTRONIC INFUSION PUMPS & SYSTEMS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): .; av. ferrocarril # 1730 int. 16 y 17; parque industrial los pinos ii; tijuana, b.c.
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 16949903
• Report Number: 3011270181-2023-00055
• Device Sequence Number: 11666115
• Product Code: MEA
• UDI-Device Identifier: 00193494001384
• UDI-Public: 00193494001384
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2023

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: 220571
• Device Lot Number: F113204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2023
• Supplement Date Received by Manufacturer: 05/18/2023
• Initial Report FDA Received Date: 05/17/2023
• Supplement Report FDA Received Date: 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2021
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN MEDICATION
• Patient Age: 55 YR
• Patient Sex: Female