MAUDE Adverse Event Report: AVANOS MEDICAL - IRVINE ON-Q PAIN RELIEF SYSTEM WITH SELECT-A-FLOW, 400 ML, 2-14 ML/HR; ELASTOMERIC - SAF

Model Number	CB004
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Numbness (2415)
Date of Event	11/27/2019
Type of Reportable Event	Serious 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 14-jan-2020 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.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).Mw5091377.
Event or Problem Description
Fill volume: unknown.Flow rate: 10 ml/hr.Procedure: total knee arthroplasty.Cathplace: adductor canal catheter.It was reported the pump delivered a large overdose of ropivacaine creating leg numbness that resolved 1-hour to 2-hours after infusion was stopped.Additional information was received on 27-dec-2019 via medwatch/ fda user facility report number, mw 5091377 event description: pt [patient] experienced almost total loss of sensation and motor function in leg below the knee while a pain pump was running.The pump was attached to an adductor canal catheter, which had been functioning normally the night before with only mild numbness at that time.When she woke up on postoperative day1 after total knee arthroplasty, her leg was very numb, she had minimal motor function, and loss of proprioception in that leg.Pump was set at 10 ml/hour and not changed throughout the process.No leakage noted.Diagnosis for use postoperative pain in knee.-cr.No additional information was provided.
Event or Problem Description
Additional information received 15-jan-2020 stated: fill volume: 550ml.Date and time infusion started: (b)(6) 2019, 16:00.Date and time infusion ended: (b)(6) 2019, 8:00.
Additional Manufacturer Narrative
All information reasonably known as of 31-jan-2020 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
This report has been confirmed a duplicate of report number 2026095-2020-00008.No additional information will be submitted for report number.Any further information concerning this event will be submitted under report number 2026095-2020-00008.
Additional Manufacturer Narrative
All information reasonably known as of 11-feb-2020 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 WITH SELECT-A-FLOW, 400 ML, 2-14 ML/HR
• Common Device Name: ELASTOMERIC - SAF
• Manufacturer (Section D): AVANOS MEDICAL - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 9595636
• Report Number: 2026095-2020-00009
• Device Sequence Number: 2423517
• Product Code: MEB
• UDI-Device Identifier: 10680651134728
• UDI-Public: 10680651134728
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K063530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/11/2020

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: Health Professional
• Device Model Number: CB004
• Device Catalogue Number: 991013472
• Device Lot Number: 0203122169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/20/2019
• Supplement Date Received by Manufacturer: 01/15/2020; 01/15/2020
• Initial Report FDA Received Date: 01/16/2020
• Supplement Report FDA Received Date: 01/31/2020; 02/11/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ROPIVICAINE 0.2%
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Weight: 68