MAUDE Adverse Event Report: AVANOS MEDICAL - IRVINE ON-Q PUMP WITH SELECT-A-FLOW AND ONDEMAND; ELASTOMERIC - COMBO

Model Number	CB005
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Numbness (2415)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is reported to be available, but has not yet been received by the manufacturer.The device history record for lot 0203128623 was reviewed and the product was produced according to product specifications.All information reasonably known as of 01 may 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 halyard health complaint database and identified as complaint (b)(4).
Event or Problem Description
Fill volume: unknown, flow rate: unknown, procedure: unknown, cathplace: unknown, infusion start time: unknown, infusion stop time: unknown.It was reported that the "bolus feature did not function properly.Pump was hooked up to patient after surgery.On pod [post-operative day] #1 anesthesia rounded on patient.Patient claimed they were very numb and didn¿t like the feeling.Anesthesia then noticed that the bolus feature was not filling correctly.The patient had never pressed the bolus but it was not full.The orange indication was not visible.The pump was replaced and sent back to pharmacy." no patient injury was reported and no symptoms of lidocaine toxicity exhibited.
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.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.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 halyard health 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 actual complaint product was returned for evaluation.The bolus button functioned as intended and observed no issues.During pca safety bolus test and bolus volume testing, results met specifications using the average bladder pressure.During pressure pot testing, the results met specification as well.There were no observed breakages on the component.The root cause could not be identified.All information reasonably known as of 22 jul 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 halyard health 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 WITH SELECT-A-FLOW AND ONDEMAND
• Common Device Name: ELASTOMERIC - COMBO
• Manufacturer (Section D): AVANOS MEDICAL - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 8579437
• Report Number: 2026095-2019-00075
• Device Sequence Number: 16540980
• Product Code: MEB
• UDI-Device Identifier: 30680651134739
• UDI-Public: 30680651134739
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/11/2020
• Device Model Number: CB005
• Device Catalogue Number: 101347300
• Device Lot Number: 0203128623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/11/2019
• Supplement Date Received by Manufacturer: 05/03/2019; 07/16/2019
• Initial Report FDA Received Date: 05/03/2019
• Supplement Report FDA Received Date: 05/23/2019; 07/23/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LIDOCAINE