MAUDE Adverse Event Report: AVANOS MEDICAL INC. ON-Q PAIN RELIEF SYSTEM, 400 ML X 8 ML/HR, PUMP; ELASTOMERIC LFR

Model Number	P400X8
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.The device history record for the reported lot number, 20076109, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.All information reasonably known as of 07-jan-2022 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.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).
Event or Problem Description
Fill volume: 550 ml.Flow rate: 8ml/hr.Procedure: left knee replacement.Cathplace: left knee area.Date of procedure: (b)(6) 2021.It was reported, "the infusion was supposed to be for 72 hours, but finished on the 16th at 11:00 pm." there was no reported injury and the patient noted there were no symptoms or leaking/wetness at site.
Additional Manufacturer Narrative
The sample device pump was received empty and was filled with saline to the reported volume of 550ml.Pressure pot testing was performed on the restrictor and the flow yielded a rates within specifications, the reported incident was not replicated.The flow rate of a pump could be affected by different external factors such as the increase of temperature and the pump position, the user and facility conditions were unknown, therefore it not possible to know if those factors contributed to the failure.Per the instructions for use (ifu) the flow rate may be higher or lower at the first and last hours of infusion, and the labeled flow rates are based on the use of normal saline as diluent, if a different diluent/drug is used the viscosity could be affected and cause the flow rate to increase.The investigation determined that the returned device functioned as intended during the sample evaluation.No defect was found; therefore, the complaint is not confirmed.Root cause could not be determined.All information reasonably known as of 18-feb-2022 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: ON-Q PAIN RELIEF SYSTEM, 400 ML X 8 ML/HR, PUMP
• 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: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 13193093
• Report Number: 2026095-2022-00001
• Device Sequence Number: 6046090
• Product Code: MEB
• UDI-Device Identifier: 00193494376123
• UDI-Public: 00193494376123
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K063530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2022

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 Expiration Date: 04/04/2024
• Device Model Number: P400X8
• Device Catalogue Number: N/A
• Device Lot Number: 20076109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2021
• Supplement Date Received by Manufacturer: 01/26/2022
• Initial Report FDA Received Date: 01/07/2022
• Supplement Report FDA Received Date: 02/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2021
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NAROPEN 0.2%
• Patient Sex: Male