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

Model Number	CB002
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Onq pump infusion completed about 24 hours earlier than expected.Patient noted pump complete at 1900.Pump should have finished at 2200 the next day.Patient reported return of motor and sensation after infusion noted to be complete.No signs of last noted.

• Brand Name: ON-Q PUMP FIXED FLOW
• Common Device Name: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 16466565
• Report Number: 16466565
• Device Sequence Number: 5263500
• Product Code: MEB
• UDI-Device Identifier: 00193494134693
• UDI-Public: 00193494134693
• 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): 02/20/2023
• Report Date (Section F): 02/20/2023

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: CB002
• Device Catalogue Number: CB002
• Device Lot Number: 30212652
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Home
• Date Report to Manufacturer: 03/02/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/02/2023
• 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: 02/20/2023