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

Model Number C SERIES

Device Problem Failure to Infuse (2340)

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

Event Date 08/23/2022

Event Type  malfunction  

Event Description

Patient went home with fluorouracil infusion pump.When he returned 46 hours later, the pump was still full.The nurse verified that all clamps were open and everything was taped as it should be.All clamps were open but the filter was no longer taped to the skin.Dressing was reinforced and patient was sent home.Patient return 24 hours later and the pump had not infused on this occasion because the clamp to the pump was not open.Patient returned on and the pump had still not infused and all clamps were open and the filter had been taped to the skin.Pump was then disconnected and returned to pharmacy.

• Brand Name: HOME PUMP C SERIES
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 15438192
• MDR Text Key: 300052662
• Report Number: 15438192
• 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: 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: C SERIES
• Device Catalogue Number: C100020
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/08/2022
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 09/16/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 30295 DA
• Patient Sex: Male