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

Model Number	INFORNG
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device was not returned to mmd for evaluation.A dhr review was completed and no non-conformances were found.Because the device was not returned to mmd an investigation could not be completed.This report is being filed because there are indications that the event occurred while the device was in use by a pediatric patient (under 18) and per our procedures all reports of this type of event that involve a pediatric patient are considered reportable.
Event or Problem Description
The initial reporter stated that the pump was over infusing and did not stop when the food ran out, that it was pumping air.Mmd did follow up with the initial reporter who stated that the patient had not experienced any adverse effects due to the complaint.No additional information was provided.[complaint (b)(4).

• Brand Name: ENTERALITE INFINITY ORANGE ENTERAL INFUSION PUMP
• Common Device Name: 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: kristin egelhoff ; 4314 zevex park lane; salt lake city, UT 84123 ; 8012641001
• MDR Report Key: 25204471
• Report Number: 1722139-2026-00134
• Device Sequence Number: 18365145
• Product Code: LZH
• UDI-Device Identifier: 10814844000334
• UDI-Public: 10814844000334
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K031199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: INFORNG
• Device Catalogue Number: INFORNG
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 05/18/2026
• Supplement Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Age: 5 MO
• Patient Sex: Unknown