MAUDE Adverse Event Report: AVANOS MEDICAL INC. ON-Q PUMP WITH SELECT-A-FLOW; ELASTOMERIC - SAF

Model Number	CB004
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Codes	Nausea (1970); Dizziness (2194); Balance Problems (4401)
Date of Event	12/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Fill volume: 550 ml.Flow rate: 10ml/hr.Procedure: carpal tunnel.Cathplace: unknown.Infusion start time: (b)(6) 2022.Infusion stop time: (b)(6) 2022.A fast flow was reported; the pump infused in 30 hours (date of procedure (b)(6) 2022); the patient experienced nausea and dizziness during infusion.The incident resolved without any medical intervention.Additional information received on 06jan2023 via medwatch/ fda user facility mw report# (b)(4) reported, the dial was set at the appropriate prescribed rate, the clamp was open; all appeared to be visibly intact.
Additional Manufacturer Narrative
The sample is reported to be available but has not yet been received by the manufacturer.A review of the device history record is in-progress.All information reasonably known as of 20 jan 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.
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.All information reasonably known as of 16 feb 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.
Additional Manufacturer Narrative
B5: correction.The actual sample from the reported event was returned for evaluation.The returned product was evaluated and no issues were observed on the device; the complaint cannot be confirmed; therefore, the root cause could not be determined.The device history record for lot 30179495 was reviewed and the product was produced according to product specifications.All information reasonably known as of 03 apr 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.
Event or Problem Description
It was reported, the patient experienced balance issues; the expected run time [on the pump] was 55 hours.

• Brand Name: ON-Q PUMP WITH SELECT-A-FLOW
• Common Device Name: ELASTOMERIC - SAF
• 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: 16224804
• Report Number: 2026095-2023-00012
• Device Sequence Number: 12112773
• Product Code: MEB
• UDI-Device Identifier: 00193494134723
• UDI-Public: 00193494134723
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Other,Health Professional,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/11/2024
• Device Model Number: CB004
• Device Lot Number: 30179495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 01/03/2023
• Supplement Date Received by Manufacturer: 01/23/2023; 03/29/2023
• Initial Report FDA Received Date: 01/23/2023
• Supplement Report FDA Received Date: 02/16/2023; 04/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/04/2022
• 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: BUPIVACAINE .1%
• Outcome Attributed to Adverse Event: Other; Life Threatening
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 72 KG