MAUDE Adverse Event Report: AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.) AVANOS HOMEPUMP C-SERIES 270ML 5ML/HR C270050; PUMP, INFUSION, ELASTOMERIC

Model Number C270050

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem Insufficient Information (4580)

Event Date 03/23/2021

Event Type  Injury  

Event Description

Patient called this morning stating she didn't think her 5fu pump was emptying properly.She came in and pharmacist estimated it was 2/3 full.(was hooked up 3/23 at 1304 and is a 46 hour pump.) i discussed with physician and he said to make a new pump with 3000mg (60% of the original pump) and infuse over 46 hours.The patient will come back on saturday for a pump disconnect.Fda safety report id# (b)(4).

• Brand Name: AVANOS HOMEPUMP C-SERIES 270ML 5ML/HR C270050
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.) ; alpharetta GA 30004
• MDR Report Key: 11602196
• MDR Text Key: 243637020
• Report Number: MW5100469
• 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: 03/29/2021

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: 03/31/2021
• 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: 62 YR
• Patient Weight: 47