MAUDE Adverse Event Report: AVANOS MEDICAL, INC. AVANOS ON-Q; PUMP, INFUSION, ELASTOMERIC

Model Number	CB004-PF
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Bupivacaine onq pump cb004 set up and initiated at approximately 14:00 to infuse at 10ml/hr for 55 hours and end at 23:00 2 days later.Upon speaking to patient, the pump emptied early in the morning estimated at 01:00.No side effects or symptoms of local anesthetic systemic toxicity (last).Nurse manager informed.

• Brand Name: AVANOS ON-Q
• Common Device Name: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 19285582
• Report Number: 19285582
• Device Sequence Number: 18057028
• Product Code: MEB
• UDI-Device Identifier: 00193494001339
• UDI-Public: (01)00193494001339
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/11/2024
• Report Date (Section F): 01/11/2024

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
• Device Model Number: CB004-PF
• Device Catalogue Number: CB004-PF
• Device Lot Number: 30181831
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Home
• Date Report to Manufacturer: 05/10/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/10/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/11/2024