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

Model Number C270050

Device Problems Failure to Deliver (2338); Infusion or Flow Problem (2964)

Patient Problem Insufficient Information (4580)

Event Date 03/10/2021

Event Type  malfunction  

Event Description

Patient arrived on friday (b)(6) 2021 to have his 46 hour fluorouracil pump taken off.When he arrived, the rn noted that none of the drug had infused, but the pump was hooked up correctly and the lock removed.The provider was contacted and the decision was made to not compound/administer another 46 hour pump.Avanos homepump c-series elastomeric pump (c270050), 270ml, 5ml/hr.Lot 30103847.It appears to be a different lot than the one that happen a few weeks back.Fda safety report id # (b)(4).

• Brand Name: AVANOS HOMEPUMP C-SERIES 270ML 5ML/HR
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.); alpharetta GA 30004
• MDR Report Key: 11561812
• MDR Text Key: 242266772
• Report Number: MW5100209
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 03/19/2021

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: C270050
• Device Lot Number: 30103847
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR
• Patient Weight: 120