MAUDE Adverse Event Report: AVANOS MEDICAL, INC. AVANOS HOMEPUMP C-SERIES, 270 ML, 5 ML/HR; PUMP, INFUSION, ELASTOMERIC

Model Number	13568
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Patient received chemotherapy treatment, which included a 5fu (fluorouracil) homepump to be attached and infuse over 46 hours.Patient was treated without incidence and discharged home with his 5fu homepump attached and infusing.No report from patient over the subsequent 46 hours until patient reported to the clinic, where he typically gets his pump disconnected on day #3 of cycle.It was discovered that the pump did not completely infuse.Oncology registered nurse (rn) was contacted, and patient was instructed to go to the cancer center for further instructions.Rn notified oncology provider and it was decided to make a 24 hour infusion homepump with 50% of dose.When patient arrived, current homepump was inspected, and it was determined patient received approximately 50% of medication in the 46 hour period.New pump was attached, and patient was discharged to home.Patient is scheduled to report back after 24 hours for pump disconnect and call if any questions or concerns arise.Lot: 30258409.Exp.11/30/2025.Homepump c-series 270 ml - 5 ml/hr.

• Brand Name: AVANOS HOMEPUMP C-SERIES, 270 ML, 5 ML/HR
• Common Device Name: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 18886072
• Report Number: 18886072
• Device Sequence Number: 7605481
• Product Code: MEB
• UDI-Device Identifier: 00193494135683
• UDI-Public: (01)00193494135683
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/07/2023
• Report Date (Section F): 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 Model Number: 13568
• Device Catalogue Number: C270050
• Device Lot Number: 30258409
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Home
• Date Report to Manufacturer: 03/12/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/12/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 11/07/2023