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

Model Number 13566

Device Problem Inaccurate Delivery (2339)

Patient Problem Nausea (1970)

Event Date 04/10/2022

Event Type  malfunction  

Event Description

"over-infusion- patient was connected to an elastomeric balloon pump to administer a 96 hr infusion of 5fu, started at 16:50.The drug was due to be completed four days later.Patient called on call provider on third day saying the infusion completed early (not exactly sure how many hours) but would have been due to complete at 1650 on fourth day.Patient was nauseated and required iv fluids in the er.Her regimen was mitomycin/5fu 96 hour infusional.Md aware.Filed report with company also.Product was disposed of.".

• 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: 14336268
• MDR Text Key: 291207972
• Report Number: 14336268
• 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: 04/29/2022

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 Model Number: 13566
• Device Catalogue Number: C270020
• 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: 04/29/2022
• Event Location: Home
• Date Report to Manufacturer: 05/09/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/09/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other