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

Model Number C270050

Device Problem Inaccurate Delivery (2339)

Patient Problem Underdose (2542)

Event Date 04/25/2019

Event Type  malfunction  

Event Description

Arrived at pt home to disconnect c-series home pump and found the home pump still had about 1/4-1/2 of its solution left to infuse.All clamps were taped open, port flushed easily with good blood return noted.Rehooked up chemo and called pharmacist.He called oncology for direction.Orders received to keep pt on infusion through tomorrow.Pt scheduled for 0900 disconnect on (b)(6) 2019.Arrived at pt's home at 0900 on (b)(6) 2019 and c-series home pump still had not infused anymore.Pt was disconnected per protocol and this c-series home pump was returned to pharmacy for evaluation.Pt is aware that he did not receive full dose of his fluorouracil.Pt's port flushed easily and good blood returned at time of de-access.Fda safety report id# (b)(4).

• Brand Name: HOMEPUMP ELASTOMERIC PUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): AVANOS MEDICAL, INC.
• MDR Report Key: 8573559
• MDR Text Key: 144116429
• Report Number: MW5086327
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2019
• 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: 0203095811
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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 Age: 58 YR
• Patient Weight: 68