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	08/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device was returned to mmd for evaluation.A dhr review was completed and did not show the currently reported issue.When the device was returned to mmdg for investigation, the pump operated as expected.Mmdg could not replicate or confirm the reported complaint.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 pumping after food was gone and did not alarm.They stated that they did not have any information about the pump settings.Mmd did follow up with the initial reporter who stated that they did not have any additional information about the complaint because it was not available.There were no adverse effects to the patient that were reported.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: 20304735
• Report Number: 1722139-2024-00513
• Device Sequence Number: 7726156
• Product Code: LZH
• UDI-Device Identifier: 10814844000341
• UDI-Public: 10814844000341
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 08/27/2024

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
• Date Returned to Manufacturer: 09/17/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2023
• 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 Sex: Prefer Not To Disclose