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

Device Problem Infusion or Flow Problem (2964)

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

Event Date 11/15/2022

Event Type  malfunction  

Event Description

The avanos homepump c-series elastometric pump (delivers 5ml/hr) was utilized to deliver fluorouracil over 46 hours on (b)(6) 2022 for this patient.However, upon return to the doctor's office after 48 hours the pump did not deliver the full amount (there was ~1/3 remaining in the pump).The nurse checked to see if there was any malfunction with the tubing but it was intact.Patient was sent home to let the remainder of the drug left in the pump to be delivered to the patient.Patient returned the following day and the pump successfully delivered the remaining amount.

• Brand Name: HOMEPUMP C-SERIES ELASTOMETRIC PUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.)
• MDR Report Key: 15940632
• MDR Text Key: 305150059
• Report Number: MW5113690
• 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: 12/05/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/07/2022
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 70 KG