MAUDE Adverse Event Report: I-FLOW LLC I-FLOW PAIN PUMP; NONE

Model Number CB004

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Dysphagia/ Odynophagia (1815); Swelling (2091)

Event Date 08/14/2013

Event Type  malfunction  

Event Description

The pt had a right shoulder arthroscopy on (b)(6) 2013.Pump infusion began approx 4:00p.M.That day and was set at 6ml/hr.The pt experienced swelling in face, arm and difficulty swallowing.The pump was noted to be almost empty at 10:00a.M.On (b)(6) 2013.Approx 300ml was infused, at that time the symptoms resolved.

• Brand Name: I-FLOW PAIN PUMP
• Type of Device: NONE
• Manufacturer (Section D): I-FLOW LLC; 20202 windrow dr.; lake forest CA 92630
• MDR Report Key: 3607579
• MDR Text Key: 4161447
• Report Number: MW5034165
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 01/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CB004
• Device Lot Number: 0200839933
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Weight: 68