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

Model Number	CBI006
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Fill volume: 400 ml, flow rate: 4 ml/hr, procedure: unknown, cathplace: unknown, infusion start time: unknown, infusion stop time: unknown.It was reported that the pump emptied in less than 24 hours without use of the bolus button.No patient injury or medical intervention was reported.Additional information received 17-aug-2021 indicated the pump was filled with 400ml ropivacaine.The patient is a palliative care patient (non-verbal).The nurse was experienced and the pump was on the patient's bed during delivery of the medication.
Additional Manufacturer Narrative
A review of the device history record is in-progress.The product involved in the report has been returned and is being processed for evaluation.This product incident is documented in the avanos medical inc.Complaint database and identified as complaint (b)(4).
Additional Manufacturer Narrative
The device history record for lot 30070743 was reviewed and the product was produced according to product specifications.The investigation remains in progress.All information reasonably known as of 24 sep 2021 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.
Event or Problem Description
Additional information received 06-sep-2021 indicated that it "seems that the bolus on-q pump was not used accordingly.".
Additional Manufacturer Narrative
One used device was returned for evaluation.Testing of the pump revealed that it met specifications for all selectable flow rates.The reported event could not be duplicated in the lab.Complaint could not be confirmed as reported.Root cause was not determined.All information reasonably known as of 28 oct 2021 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 PUMP WITH SELECT-A-FLOW AND ONDEMAND
• Common Device Name: ELASTOMERIC - COMBO
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 12422807
• Report Number: 2026095-2021-00090
• Device Sequence Number: 11677957
• Product Code: MEB
• UDI-Device Identifier: 00193494134839
• UDI-Public: 00193494134839
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K063530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/29/2021

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: 06/24/2022
• Device Model Number: CBI006
• Device Catalogue Number: N/A
• Device Lot Number: 30070743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/13/2021
• Supplement Date Received by Manufacturer: 09/06/2021; 10/19/2021
• Initial Report FDA Received Date: 09/03/2021
• Supplement Report FDA Received Date: 09/24/2021; 10/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ROPIVACAINE 2MG/ML
• Patient Weight: 54