MAUDE Adverse Event Report: MOOG MEDICAL DEVICES GROUP ENTERALITE INFINITY ORANGE ENTERAL INFUSION PUMP

Model Number INFKIT2

Device Problem Failure to Auto Stop (2938)

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

Event Date 11/13/2019

Event Type  malfunction  

Manufacturer Narrative

This device was returned to mmdg for evaluation.A dhr review was completed and found no non-conformances associated with the device.During the investigation the pump operated as expected.The pump history was also reviewed, and there is no indication that the complaint occurred as reported.This report is being filed because the event occurred while the device was in use by a pediatric patient.Per our procedures all reports of this type of event that involve a pediatric patient are considered reportable.

Event Description

The initial reporter stated the pump "is now occasionally pumping air into her child's belly".The initial reporter also stated that the patient is fine.The patient did not have any adverse effects due to the complaint.(b)(4).

• Brand Name: ENTERALITE INFINITY ORANGE ENTERAL INFUSION PUMP
• Type of Device: ENTERAL INFUSION PUMP
• Manufacturer (Section D): MOOG MEDICAL DEVICES GROUP; 4314 zevex park lane; salt lake city UT 84123
• Manufacturer (Section G): MOOG MEDICAL DEVICES GROUP; 4314 zevex park lane; salt lake city UT 84123
• Manufacturer Contact: ariann dalton ; 4314 zevex park lane; salt lake city, UT 84123 ; 8012641001
• MDR Report Key: 9535438
• MDR Text Key: 174179720
• Report Number: 1722139-2019-00424
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: INFKIT2
• Device Catalogue Number: INFKIT2
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2019
• Date Manufacturer Received: 12/02/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1