MAUDE Adverse Event Report: AVANOS MEDICAL - IRVINE ON-Q PAIN RELIEF SYSTEM WITH DUAL SOAKER CATHETERS, 400 ML, 4 ML/HR (2+2 ML/HR); ELASTOMERIC LFR

Model Number	PS12508
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Death (1802)
Date of Event	12/07/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of (b)(6) 2019 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: 420 ml.Flow rate: 4 ml/hr.Procedure: right hepatectomy plus cholecystectomy.Cathplace: preperitoneal left and right abdominal.Date time infusion started: (b)(6) 2018 7:30 pm.Date time infusion stopped: (b)(6) 2018 6:30 pm.It was reported the patient was using an elastomeric device.The patient passed away following a hepatectomy procedure on post operative day (pod) 4.The patient had not received ropivacaine 0.2% in the past.The patient did not exhibit any drug related symptoms or side effects.The clinicians are unsure if the event was related to the use of the device and unsure if there was any absorption of the ropivacaine into the circulatory system.The elastomeric device was not empty at the end of infusion and time of disconnection.The reported environmental conditions of the device during use were moderately cool, low humidity and the device was under blankets while in use on the patient.The patient eventually developed arrhythmias.The device was removed pod 2, the clinicians were unsure regarding the cause of the patient's cardiac arrhythmias in relation to the ropivacaine.On (b)(6) 2018 additional information was received stating the patient developed fast atrial fibrillation (af) and arrhythmias with multiple episodes of hypotension.The patient died on (b)(6) 2018 due to severe myocardial infarct (mi) post-hepatectomy.
Additional Manufacturer Narrative
All information reasonably known as of 28-mar-2019 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 DUAL SOAKER CATHETERS, 400 ML, 4 ML/HR (2+2 ML/HR)
• Common Device Name: ELASTOMERIC LFR
• Manufacturer (Section D): AVANOS MEDICAL - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 8211832
• Report Number: 2026095-2019-00001
• Device Sequence Number: 11460988
• Product Code: MEB
• UDI-Device Identifier: 30680651136238
• UDI-Public: 30680651136238
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K063530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PS12508
• Device Catalogue Number: 101364900
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/14/2018
• Supplement Date Received by Manufacturer: 03/05/2019
• Initial Report FDA Received Date: 01/03/2019
• Supplement Report FDA Received Date: 04/01/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ROPIVACAINE 0.25% , NORMAL SALINE; ROPIVACAINE 0.25% , NORMAL SALINE
• Outcome Attributed to Adverse Event: Death
• Patient Age: 69 YR
• Patient Weight: 36