MAUDE Adverse Event Report: AVANOS MEDICAL, INC. ON-Q SYSTEM SAF 400MLX2-14ML/HR; ELASTOMERIC - SAF

Model Number CB004

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

Patient Problems Tinnitus (2103); No Code Available (3191)

Event Date 06/10/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The actual complaint product was not returned for evaluation, however, photos were provided.The device history record for lot 30004422 was reviewed and the product was produced according to product specifications.All information reasonably known as of 22 jun 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 complaint database and identified as complaint (b)(4).

Event Description

Fill volume: 545ml.Flow rate: saf 10/saf 14 for bolus.Procedure: ankle replacement.Cathplace: ankle.Infusion start time: (b)(6) 2020.Infusion stop time: (b)(6) 2020 12:00 pm.It was reported by the patient to the nurse hotline that the patient experienced oral numbness and a metallic taste in his mouth, as well as a very dry mouth.The patient also reported a ringing in his ears, though he also reported that he has a history of that condition, so it may not be related.The patient spoke to the anesthesia department, who advised him to clamp off the pump, and after three hours, the patient reports that the symptoms resolved.The pump was removed.The patient reports that the select-a-flow (saf) was set at 10, and that he gave himself 3 boluses the night of (b)(6) 2020 by turning the saf to 14 for a couple hours, then turning it back to 10.The pump had been placed on (b)(6) 2020 to treat post surgical pain.The pump was filled with 0.2% ropivicaine.No further information provided.

Manufacturer Narrative

Photos of the device provided by the customer were reviewed, however, no root cause for the reported issue could be determined.All information reasonably known as of 23 jul 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 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 SYSTEM SAF 400MLX2-14ML/HR
• Type of Device: ELASTOMERIC - SAF
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 10191655
• MDR Text Key: 196747684
• Report Number: 2026095-2020-00107
• 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: 07/27/2020

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: 03/27/2022
• Device Model Number: CB004
• Device Catalogue Number: N/A
• Device Lot Number: 30004422
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/10/2020
• Initial Date FDA Received: 06/24/2020
• Supplement Dates Manufacturer Received: 07/13/2020
• Supplement Dates FDA Received: 07/27/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 49 YR
• Patient Weight: 93