MAUDE Adverse Event Report: AVANOS MEDICAL, INC. HOME INFUSOR C SERIES 5_FU INFUSION PUMP; PUMP, INFUSION, ELASTOMERIC

Lot Number 30182064

Device Problem Failure to Infuse (2340)

Patient Problem Insufficient Information (4580)

Event Date 07/22/2022

Event Type  malfunction  

Event Description

On (b)(6) 2022 patient started 46 hour infusion of fluorouracil 4.025 mg in ns 24 1 ml at infusion center.On (b)(6) 2022 patient came to infusion room for a c series disconnect.It was noted that pump was not decompressed and 5 fu did not infuse.All line clamps were open and verified, ball was connected correctly.Port flushed without difficulty and good blood return was noted.Orders for infusion were discontinued and patient to receive next treatment as scheduled.Fda safety report id# (b)(4).

• Brand Name: HOME INFUSOR C SERIES 5_FU INFUSION PUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): AVANOS MEDICAL, INC.
• MDR Report Key: 15121385
• MDR Text Key: 296856116
• Report Number: MW5111152
• 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: 07/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 30182064
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White