MAUDE Adverse Event Report: AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.) AVANOS ON-Q PUMP WITH ONDEMAND; PUMP, INFUSION, ELASTOMERIC

Model Number CB003

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 07/11/2023

Event Type  malfunction  

Event Description

Cb004 tubing for on-q pump was leaking from the filter site.Lot #30208385.

• Brand Name: AVANOS ON-Q PUMP WITH ONDEMAND
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.); alpharetta GA 30004
• MDR Report Key: 17337192
• MDR Text Key: 319380642
• Report Number: MW5119521
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CB003
• Device Lot Number: 30208385
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Sex: Female