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

Model Number C270050

Device Problem Defective Device (2588)

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

Event Date 02/18/2021

Event Type  malfunction  

Event Description

Page 2 of 9.The patient arrived on saturday to have his 46 hour fluorouracil pump taken off.When he arrived, the rn noted that none of the drug had infused.The patient stated he noticed the pump wasn't getting smaller on friday but failed to call the office as our patients are all instructed.The rn contacted the oncologist on call, who initially said he wanted the pump remade and put on.Rn stated there was no one to mix it, plus the patient was due for udenyca since he'd received oxaliplatin and irinotecan on thursday and if they put a new pump on, then it's 2 more days and we'd have to delay the following cycle because the time from udenyca to chemo would be too close.Physician said pull the pump off and give udenyca.Rn called the oncology pharmacist to let her know and physician texted the oncology pharmacist to let her know.We are assuming it's a defective pump.The company won't take them back anymore for investigation due to covid.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. / HALYARD HEALTH INC. ; alpharetta GA 30004
• MDR Report Key: 11421816
• MDR Text Key: 238383951
• Report Number: MW5099803
• 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: 03/02/2021

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: 30101331
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Weight: 57