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

Model Number C270050

Device Problem Failure to Infuse (2340)

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

Event Date 01/28/2021

Event Type  malfunction  

Event Description

On (b)(6) 2021, at the (b)(6) cancer center, the patient received an extended infusion of 5fu to be infused over 48.2 hours at home.The total volume was 241 ml to be infused at a rate of 5 ml/hour.Two days later, the patient returned to the cancer center, and none of the medication was infused.The pump used was the avanos homepump c-series elastomeric pump.The lot number is 20040309.Therefore, the patient had to be re-treated with a new dosi-pump on (b)(6) 2021.Fda safety report id# (b)(4).

• Brand Name: AVANOS HOMEPUMP C-SERIES ELASTOMERIC PUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): AVANOS MEDICAL, INC. ; alpharetta GA 30004
• MDR Report Key: 11272366
• MDR Text Key: 230272361
• Report Number: MW5099155
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): Y
• 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: 01/29/2021

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: Health Professional
• Device Model Number: C270050
• Device Lot Number: 20040309
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 36 YR
• Patient Weight: 85