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

Model Number 5FU

Device Problem Application Program Problem: Medication Error (3198)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/02/2023

Event Type  malfunction  

Event Description

Patient had 5-fluorouracil (5fu) pump (bulb) put on.When she returned for her appointment for removal, the bulb was not empty.It did not appear that she had gotten any of the medication.Informed pharmacy and the provider.Provider requested that the patient get another bulb applied with 5fu and wear it for another 46 hours.

• Brand Name: 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: 17181281
• MDR Text Key: 317690882
• Report Number: 17181281
• 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: 06/05/2023

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: 5FU
• Device Lot Number: 20096644
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/05/2023
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 06/22/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/22/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1