MAUDE Adverse Event Report: I-FLOW LLC HOME PUMP ECLIPSE C-SERIES 270 ML/2ML/HR; ELASTOMETRIC PUMP

Lot Number 0201022130

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Dehydration (1807); Inflammation (1932); Overdose (1988)

Event Date 02/10/2014

Event Type  Injury  

Event Description

Pt received 5-fu via elastometric pump.Med infused over 4 days rather than 5 days.No sign of overt leakage.Hospitalized for mucositis, stomatitis, dehydration, malnutrition.Tubing attached to pump is available.

• Brand Name: HOME PUMP ECLIPSE C-SERIES 270 ML/2ML/HR
• Type of Device: ELASTOMETRIC PUMP
• Manufacturer (Section D): I-FLOW LLC; 20202 windrow dr.; lake forest CA 92630
• MDR Report Key: 3652781
• MDR Text Key: 4314134
• Report Number: MW5034741
• 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: 02/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2015
• Device Lot Number: 0201022130
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/27/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TUBING ATTACHED TO PUMP IS AVAILABLE
• Patient Outcome(s): Hospitalization
• Patient Age: 59 YR
• Patient Weight: 66