MAUDE Adverse Event Report: AVANOS MEDICAL - IRVINE ON-Q PUMP FIXED FLOW; ELASTOMERIC LFR

Model Number CB001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dysphagia/ Odynophagia (1815); Pyrosis/Heartburn (1883); Low Blood Pressure/ Hypotension (1914); Tinnitus (2103); Dizziness (2194); Numbness (2415); No Code Available (3191)

Event Date 05/07/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).A review of the device history record is in-progress.The actual complaint product was not returned for evaluation.Root cause could not be determined.All information reasonably known as of 27 may 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).

Event Description

Fill volume: 550 ml.Flow rate: 5 ml/hr.Procedure: left shoulder arthroscopy with rotator cuff repair and bone spur removal.Cathplace: "at nerve leading down into the shoulder mid clavic side of neck and shoulder." infusion start time: (b)(6) 2020 unknown start time.Infusion stop time: (b)(6) 2020 22:00.Patient reported inability to move fingers and could not move elbow.The patient then developed severe reflex, heart burn, ineffective cough.Numbness from shoulder progressed towards middle of chest and began having difficulty breathing, difficulty swallowing, ringing in ears.Patient developed dry mouth, dizziness, was cold and clammy, had blood pressure of 65/37.Patient called 911 around 10 pm and clamped off medication as she thought it might be related.911 came and blood pressure was up to 132/77 when they measured it again.Patient advised to immediately clamp off the on q pump and call her doctor as she may be experiencing an adverse reaction to the medication.Patient said she felt better once medication was clamped off.Remaining symptoms are hoarse voice, difficulty swallowing, ineffective cough.Additional information received 08-may-2020 indicated the patient was able to contact her physician and was advised to disconnect the pump as "they were unsure if it was toxicity or another adverse event." the patient said when she woke up her symptoms were resolved.The pump had been clamped off since about 10 pm the night before.

Manufacturer Narrative

The device history record for lot 0203063628 was reviewed and the product was produced according to product specifications.Root cause could not be determined.All information reasonably known as of (b)(6) 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 PUMP FIXED FLOW
• Type of Device: ELASTOMERIC LFR
• Manufacturer (Section D): AVANOS MEDICAL - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 10097262
• MDR Text Key: 194465303
• Report Number: 2026095-2020-00074
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• PMA/PMN Number: K063530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 06/26/2020

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/03/2021
• Device Model Number: CB001
• Device Catalogue Number: 101346702
• Device Lot Number: 0203063628
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/07/2020
• Initial Date FDA Received: 05/28/2020
• Supplement Dates Manufacturer Received: 06/17/2020
• Supplement Dates FDA Received: 06/26/2020
• Patient Sequence Number: 1
• Treatment: ROPIVACAINE 0.125%
• Patient Outcome(s): Other
• Patient Age: 54 YR