MAUDE Adverse Event Report: AVANOS MEDICAL, INC. 5-FU HOMEPUMP C-SERIES; PUMP, INFUSION, ELASTOMERIC

Model Number C SERIES

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 08/26/2021

Event Type  malfunction  

Event Description

5 fu pump leaked through the filter.

• Brand Name: 5-FU HOMEPUMP C-SERIES
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 12480355
• MDR Text Key: 271662856
• Report Number: 12480355
• 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: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: C SERIES
• Device Catalogue Number: C100020
• Device Lot Number: 30109132
• 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: 09/01/2021
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 09/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1