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

Model Number C270050

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Pain (1994); Ulcer (2274)

Event Date 03/14/2022

Event Type  malfunction  

Event Description

On (b)(6) 2022 patient returned to our infusion center for treatment.She stated that on (b)(6) 2022 she was to receive fluorouracil 4250mg in 241 ml total volume to infuse over 48 hours in a avanos homepump device ( (b)(4) and lot number 20074842).The patient stated the entire dose infused over 24 hours (not 48 hours).The patient did not inform the infusion center of the problem at the time of the event.She stated that she did develop some sores on her tongue and "felt sick" for approximately a week.Diagnosis for use: rectal cancer.Fda safety report id # (b)(4).

• Brand Name: AVANOS HOMEPUMP C-SERIES ELASTOMERIC PUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.)
• MDR Report Key: 13995529
• MDR Text Key: 288610862
• Report Number: MW5108723
• 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: 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C270050
• Device Lot Number: 20074842
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FLUOROURACIL
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 71 KG
• Patient Ethnicity: Non Hispanic