MAUDE Adverse Event Report: AVANOS MEDICAL, INC. HALYARD; PUMP, INFUSION, ELASTOMERIC

Model Number	13467
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/23/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Pain management decided to send a patient home with an on-q pump.It was delivered to the floor and a few minutes later nursing staff reported to pharmacy that the medication was spraying everywhere from the tubing.The filter on the tubing was spraying ropivacaine everywhere.The pharmacist looked at the manufactures website to try and find a reason for this and asked fellow pharmacy colleagues if they had ever seen or heard of this happening and they hadn't.The new ball came up in about twenty minutes and within that time the other pump had completely drained.Luckily, it was in the sink and the patient hadn't gone home with the faulty product.The new one worked like it should.The faulty on-q pump was placed back in its original packaging just in case it was needed for follow-up.

• Brand Name: HALYARD
• Common Device Name: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 8304482
• Report Number: 8304482
• Device Sequence Number: 13699545
• Product Code: MEB
• UDI-Device Identifier: 10680651134674
• UDI-Public: (01)10680651134674(20)
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 01/11/2019
• Report Date (Section F): 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 13467
• Device Catalogue Number: CB001
• Device Lot Number: 0203086612
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/05/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/11/2019