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

Model Number 5FU PUMP C SERIES

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 09/30/2021

Event Type  malfunction  

Event Description

Patient came in to have home infusion pump removed.Noticed dry white powder of fluorouracil on the outside of the small filter.Avanos c-series pump, 270 ml (5ml/hr).Lot 30124764.

• Brand Name: AVANOS HOMEPUMP C-SERIES ELASTOMERIC PUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 12597713
• MDR Text Key: 275403401
• Report Number: 12597713
• 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: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 5FU PUMP C SERIES
• Device Lot Number: 30124764
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2021
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 10/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1