MAUDE Adverse Event Report: AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.) C-SERIES PUMP; PUMP, INFUSION, ELASTOMERIC

Model Number C270050 - 270 ML, 5 ML/HR

Device Problems Insufficient Flow or Under Infusion (2182); Pumping Problem (3016)

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

Event Date 12/30/2022

Event Type  malfunction  

Event Description

C-series home pump containing fluorouracil / ns mixture dosed at 2400mg/m2/dose (4200mg) iv over 46 hours was started on (b)(6) at 1118 at infusion center with dual rn sign off.Flow restrictor taped to skin, verified clamps are open and verified infusion rate on mar matches c-series pump.On (b)(6) 2022 patient returned to infusion center for scheduled pump disconnect.It was identified that the pump failed to completely deliver its contents.On examination it was estimated that approximately 70% of the contents had infused.A reason for the incomplete discharge of the pump contents could not be determined.All connections intact, there were no kinks in the line, the sensor was still taped to the patients' abdomen, huber needle in place.The patient's port was functioning and had good blood return.The pump was disconnected, and no attempt was made infuse the remainder.Provider notified.

• Brand Name: C-SERIES PUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.)
• MDR Report Key: 16132086
• MDR Text Key: 307082987
• Report Number: MW5114238
• 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: 01/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C270050 - 270 ML, 5 ML/HR
• Device Lot Number: 30209731
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: FLUOROURACIL 4200 MG (B)(6) 2022
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White