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

Catalog Number INF0500-A

Device Problem Hole In Material (1293)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

Patient was using an enteralite infinity feeding pump and bag.When the nurse took the bag out of the package, and filled it with feeding for the patient, it was noted that the bag had a hole in it.In getting a second bag, this too had a hole.Manufacturer response for enteralite infinity 500 ml bag, (brand not provided) (per site reporter): they are wanting the device in question along with 2 unopened packages.

• 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: 6431415
• MDR Text Key: 70780988
• Report Number: 6431415
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/27/2017,03/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: INF0500-A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/27/2017
• Event Location: Hospital
• Date Report to Manufacturer: 02/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Age: 11 YR