MAUDE Adverse Event Report: HALYARD / AVANOS MEDICAL, INC. HALYARD HOMEPUMP C-SERIES, 270ML 5ML/HR; PUMP, INFUSION, ELASTOMERIC

Model Number C-SERIES

Device Problems Fluid/Blood Leak (1250); Material Separation (1562)

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

Event Date 12/04/2020

Event Type  Injury  

Event Description

Patient had a 5fu pump put on (b)(6) 2020.He woke up at 0300 on (b)(6) 2020 and noticed that there was a large wet spot on his sheet from where it had leaked.He immediately got up, gloved, clamped it off, and put it in the supplied chemo bag.He brought it to the office first thing in the morning.The line had come apart where it shouldn't ever come apart.Fda safety report id# (b)(4).

• Brand Name: HALYARD HOMEPUMP C-SERIES, 270ML 5ML/HR
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): HALYARD / AVANOS MEDICAL, INC.
• MDR Report Key: 10991572
• MDR Text Key: 221246116
• Report Number: MW5098310
• Device Sequence Number: 1
• Product Code: MEB
• 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: 12/08/2020

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
• Device Operator: Lay User/Patient
• Device Model Number: C-SERIES
• Device Lot Number: 30049140
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/10/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Weight: 100