MAUDE Adverse Event Report: AVANOS MEDICAL - IRVINE ON-Q C-BLOC WITH DUAL SELECT-A-FLOW 600 ML X 1-7 ML/HR + 1-7 ML/HR; ELASTOMERIC - SAF

Model Number	CB6007
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Lethargy (2560)
Date of Event	10/28/2019
Type of Reportable Event	Serious Injury
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 18-nov-2019 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.This product incident is documented in the avanos medical, inc.Complaint database and identified as complaint (b)(4).The device was not returned.
Event or Problem Description
Fill volume: unknown.Flow rate: unknown.Procedure: unknown.Cathplace: unknown.Start date/time of infusion ¿ friday, (b)(6) 2019, 3pm.Stop date/time of infusion ¿ monday, (b)(6) 2019, 10am.It was reported the patient experienced hypotension and was lethargic when the device was in use.The symptoms started with initiation of the therapy and were resolved with discontinuation of the device.Additional information received 05-nov-2019 stated the "patient had a toxicity reaction so there was concern that the pump was in a fast flow state.".
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.All information reasonably known as of 23-dec-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.
Additional Manufacturer Narrative
The device history record for the reported lot number, 0002990522, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.One on-q dual select-a-flow (saf) pump and two silver soaker catheters were received.The first silver soaker catheter and the second silver soaker were noted to be undamaged (i.E., no kinks bends, cuts, etc.) the saf pump was evaluated.Flow testing and pressure testing was performed and the device met specifications.The device failure was not reproduced in the lab and was not confirmed.A root cause was not identified.All information reasonably known as of 28-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 comp-ghc-19-03377.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 C-BLOC WITH DUAL SELECT-A-FLOW 600 ML X 1-7 ML/HR + 1-7 ML/HR
• Common Device Name: ELASTOMERIC - SAF
• Manufacturer (Section D): AVANOS MEDICAL - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 9358181
• Report Number: 2026095-2019-00187
• Device Sequence Number: 16703714
• Product Code: MEB
• UDI-Device Identifier: 10680651134773
• UDI-Public: 10680651134773
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K063530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/28/2020

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 Expiration Date: 11/14/2021
• Device Model Number: CB6007
• Device Catalogue Number: 101347704
• Device Lot Number: 0002990522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/28/2019
• Supplement Date Received by Manufacturer: 12/02/2019; 02/07/2020
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 12/23/2019; 02/29/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 0.2% ROPIVACAINE
• Outcome Attributed to Adverse Event: Other