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

Model Number REF C270050

Device Problem Failure to Infuse (2340)

Patient Problem Insufficient Information (4580)

Event Date 10/27/2020

Event Type  malfunction  

Event Description

Patient received chemotherapy on (b)(6) 2020 at infusion center.Fluorouracil ordered as a take home infusion pump.Infusion was to have finished on (b)(6) 2020.It did not infuse.Patient checked on (b)(6) 2020.Pump was assessed.Patient sent home with pump.Patient returned on (b)(6) 2020.Pump still did not infuse.Pharmacy to chairside to assess pump.Provider made aware.Fda safety report id# (b)(4).

• Brand Name: HOMEPUMP C-SERIES ELASTOMERIC PUMP - 270ML - 5ML/HR
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): HALYARD HEALTH, INC. / AVANOS MEDICAL, INC.
• MDR Report Key: 10860284
• MDR Text Key: 217110440
• Report Number: MW5097941
• Device Sequence Number: 1
• Product Code: MEB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 11/13/2020

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: Other
• Device Expiration Date: 02/03/2023
• Device Model Number: REF C270050
• Device Lot Number: 20034838
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/17/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Weight: 131