MAUDE Adverse Event Report: AVANOS MEDICAL, INC. ON-Q PAIN RELIEF SYSTEM WITH SELECT-A-FLOW; PUMP, INFUSION, ELASTOMERIC

Model Number 13472

Device Problems Excess Flow or Over-Infusion (1311); Application Program Problem: Medication Error (3198)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/19/2022

Event Type  malfunction  

Event Description

Onq bupivacaine 0.2% at 10ml/hr due to be empty at 1830.Patient reports onq empty at 0800.Rate regulator set at 10ml/hr checked by patient.Infusion possibly ran in at a faster rate ending sooner than anticipated.

• Brand Name: ON-Q PAIN RELIEF SYSTEM WITH SELECT-A-FLOW
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 16067800
• MDR Text Key: 306360260
• Report Number: 16067800
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/06/2022

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 Operator: Lay User/Patient
• Device Model Number: 13472
• Device Catalogue Number: CB004
• Device Lot Number: 30155153
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/06/2022
• Event Location: Home
• Date Report to Manufacturer: 12/29/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/29/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1