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

Device Problems Device Alarm System (1012); Defective Device (2588)

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

Event Date 11/26/2019

Event Type  malfunction  

Event Description

Enteral feeding pump did not alarm when formula had run out and continued to run.Either feeding bag or enteral pump were defective.Examine both items for potential defect.Pump replaced with new pump.Equipment taken to inspection room; informed biomedical engineering.

• Brand Name: ENTERALITE INFINITY
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): ZEVEX, INC; 4314 zevex park lane; salt lake city UT 84123
• MDR Report Key: 9503456
• MDR Text Key: 172249957
• Report Number: 9503456
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/12/2019
• Event Location: Hospital
• Date Report to Manufacturer: 12/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 5475 DA