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

Model Number HOMEPUMP C-SERIES 270ML 5ML/HR

Device Problem Failure to Deliver (2338)

Patient Problem Underdose (2542)

Event Date 06/19/2020

Event Type  malfunction  

Event Description

Patient was prescribed a 5-fluorouracil home infusion to be administered via an elastomeric pump over 46 hours.Administration began on wednesday (b)(6) 2020.When the patient returned to have the infusion unhooked on friday (b)(6) 2020, the nurse noticed the infuser pump was completely full and very little, if any, medication had been delivered to the patient.After investigation of the process, it was noted that the pump was filled and hooked up to the patient appropriately.The pump tubing had been primed with 0.9% sodium chloride and fluid had made it completely through the tubing down to the patient end.The patient's port flushed appropriately.When the pump was tested after removal from the patient, the fluid did not flow as it should, indicating a defect in the pump.The manufacturer was notified of the issue.Fda safety report id# (b)(4).

• Brand Name: HALYARD HOMEPUMP C-SERIES
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): HALYARD HEALTH/ AVANOS MEDICAL INC
• MDR Report Key: 10200032
• MDR Text Key: 196771368
• Report Number: MW5095222
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 06/22/2020

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 Operator: Health Professional
• Device Model Number: HOMEPUMP C-SERIES 270ML 5ML/HR
• Device Lot Number: 30021386
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/25/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1