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

Lot Number 30025869

Device Problem Improper Flow or Infusion (2954)

Patient Problem Inadequate Pain Relief (2388)

Event Date 11/12/2020

Event Type  malfunction  

Event Description

Patients utilizing the on-q elastomeric pump 400 ml with ropivacaine 0.2%, had pump empty after 16 hours instead of intended 55-72 hour infusion duration, resulting in several hours of no pain relief as promised.Most patients discharged and unable to provide another pump.Fda safety report id # (b)(4).

• Brand Name: ON-Q BALL / ON Q ELASTOMERIC PUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): AVANOS MEDICAL, INC.
• MDR Report Key: 10934132
• MDR Text Key: 219379140
• Report Number: MW5098163
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 11/25/2020

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: Health Professional
• Device Lot Number: 30025869
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other