MAUDE Adverse Event Report: AVANOS MEDICAL, INC. HOMEPUMP C-SERIES MODEL C-270050 ELASTOMERIC PUMP; PUMP, INFUSION, ELASTOMERIC

Lot Number 30182064

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

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

Event Date 06/10/2022

Event Type  malfunction  

Event Description

Patient arrived to infusion center for pump disconnect of 5 fu pump connected 48 hours earlier.Noted pump not fully decompressed.Reviewed with pharmacist who estimated approximately half of chemotherapy infused.Pt did not wish to remain connected.Ordering provider made aware.Fda safety report id # (b)(4).

• Brand Name: HOMEPUMP C-SERIES MODEL C-270050 ELASTOMERIC PUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): AVANOS MEDICAL, INC.
• MDR Report Key: 14788265
• MDR Text Key: 294671548
• Report Number: MW5110466
• 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: 06/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2022
• 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
• Treatment: FLUOROURACIL 750 MG
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White