MAUDE Adverse Event Report: ZEVEX, INC. ENTERALITE INFINITY ADMINISTRATION SETS; PUMP, INFUSION, ENTERAL

Model Number INF1200-A

Device Problem Air Leak (1008)

Patient Problem No Information (3190)

Event Date 06/11/2018

Event Type  malfunction  

Event Description

Feeding bag noted to have air in portion distal to actual pump mechanism.Pump continued pumping, no alarms for air in line.Tubing removed and replaced.

Event Description

Feeding bag noted to have air in portion distal to actual pump mechanism.Pump continued pumping, no alarms for air in line.Tubing removed and replaced.

• Brand Name: ENTERALITE INFINITY ADMINISTRATION SETS
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): ZEVEX, INC.; 4314 zevex park lane; salt lake city UT 84123
• MDR Report Key: 7633735
• MDR Text Key: 112198540
• Report Number: 7633735
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: INF1200-A
• Device Catalogue Number: INF1200-A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/13/2018
• Event Location: Hospital
• Date Report to Manufacturer: 06/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1