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

Device Problems Break (1069); Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2019

Event Type  No Answer Provided  

Event Description

Woman called to report she had an on-q pump for a femur/knee fracture.She was in a rehab for 4 days before the nurse noticed it was not working and never infused anything.The staff took the pump, said it was broken and never told her what the problem was.She wanted to report it to us.(b)(4).

• Brand Name: ON-Q PUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): AVANOS MEDICAL, INC.
• MDR Report Key: 9829261
• MDR Text Key: 184058503
• Report Number: MW5093735
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1