MAUDE Adverse Event Report: I-FLOW CORPORATION HOMEPUMP C-SERIES

Lot Number 0202195126

Device Problem Insufficient Flow or Under Infusion (2182)

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

Event Date 12/30/2015

Event Type  malfunction  

Event Description

A 5fu pump was set to infuse total volume over 2 days, and only 25 percent of the volume infused in the 2 days.Dates of use: (b)(6) 2015.

• Brand Name: HOMEPUMP C-SERIES
• Type of Device: HOMEPUMP C-SERIES
• Manufacturer (Section D): I-FLOW CORPORATION; lake forest CA 92630
• MDR Report Key: 5357924
• MDR Text Key: 35621054
• Report Number: MW5059153
• Device Sequence Number: 1
• Product Code: MEB
• 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: 01/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 0202195126
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 69 YR