MAUDE Adverse Event Report: IFLOW HOMEPUMP C-SERIES

Model Number 270/10

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/15/2015

Event Type  malfunction  

Event Description

Multiple failures of elastomeric pump to infuse over proper period of time (under-infusion of a 24-hr dose).Occurred from (b)(6) 2015 to present ((b)(6) 2016).Seven patients total.All using the 270/10 model of the i-flow home pump c-series elastomeric infusion device.Three total lot#'s involved: 0202245400; 020189173; 0202177860.No serious injury or hospitalization was resulted.Patients were under-infused the proper dose of antibiotics.Patients were switched to an alternate pump.Dates of use: (b)(6) 2015 - (b)(6) 2016.Reason for use: continuous antibiotic infusion.

• Brand Name: HOMEPUMP C-SERIES
• Type of Device: HOMEPUMP C-SERIES
• Manufacturer (Section D): IFLOW
• MDR Report Key: 5454807
• MDR Text Key: 38874250
• Report Number: MW5060398
• Device Sequence Number: 2
• Product Code: MEB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/19/2016
• 3 Devices were Involved in the Event: 1 2 3

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: 270/10
• Device Lot Number: 020189173
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/19/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1