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

Model Number C270050

Device Problem Failure to Deliver (2338)

Patient Problem Insufficient Information (4580)

Event Date 03/08/2022

Event Type  malfunction  

Event Description

Elastomeric portable pump containing fluorouracil did not deliver the medication.The portable pump was supposed to run for 5ml/hr.Prior to dispensing the pump, the line was primed and clamped without issues.Fda safety report id # (b)(4).

• Brand Name: AVANOS HOMEPUMP C-SERIES ELASTOMERIC PUMP 5ML/HR.
• Type of Device: PUMP, INFUSION, ELASTOMERIC.
• Manufacturer (Section D): AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.); alpharetta GA 30004
• MDR Report Key: 13770366
• MDR Text Key: 287352602
• Report Number: MW5108149
• 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: 03/10/2022

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 Model Number: C270050
• Device Lot Number: 30164024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/14/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 86 KG