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

Catalog Number C270050

Patient Problem Insufficient Information (4580)

Event Date 10/22/2023

Event Type  malfunction  

Event Description

The patient presented to the aic (ambulatory infusion center) for pump removal, and it was determined that the chemotherapy had not been infused via the pump.It was weighed to have approximately 235g of volume and the pumps are filled to 240ml.

• Brand Name: AVANOS HOMEPUMP C-SERIES
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 18169105
• MDR Text Key: 328529155
• Report Number: 18169105
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 11/13/2023,11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: C270050
• Device Lot Number: 30258409
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/13/2023
• Event Location: Home
• Date Report to Manufacturer: 11/20/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/20/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21170 DA
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Race: White