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

Model Number C-SERIES 270ML 5ML/HR

Device Problems Inaccurate Flow Rate (1249); Use of Device Problem (1670)

Patient Problem Insufficient Information (4580)

Event Date 06/06/2023

Event Type  Other  

Event Description

Incorrect eclipse pump used to infuse patient; 5fu infused over approximately 24hrs, as opposed to the prescribed 96hrs.

• Brand Name: C-SERIES ECLIPSE PUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.)
• MDR Report Key: 17288470
• MDR Text Key: 318755599
• Report Number: MW5119232
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 07/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: C-SERIES 270ML 5ML/HR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FLUOROURACIL- 06/05/2023-06/06/2023
• Patient Outcome(s): Other
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 104 KG