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

Model Number	INFKIT2
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to mmd for evaluation.A dhr review was completed and does not show the currently reported issue.Because the device was not returned to mmd, an investigation could not be completed.This report will be updated if the device is returned to mmdg.
Event or Problem Description
The initial reporter stated that the pump was not delivering as expected and that there was also no alarm.They stated they did not have any information about the rate or dose settings, but that the pump did not deliver anything.Mmd did not follow up with the initial reporter.They had already stated that the complaint occurred during testing and had not affected a patient.No other information was provided.(b)(4).
Additional Manufacturer Narrative
The device was returned to mmd for evaluation.A dhr review was completed and does not show the currently reported issue.When the device was returned to mmd for investigation, it operated as expected.Mmd could not replicate or confirm the reported complaint.Based on this information, no mdr would have been required.
Event or Problem Description
The initial reporter stated that the pump was not delivering as expected and that there was also no alarm.They stated they did not have any information about the rate or dose settings, but that the pump did not deliver anything.Mmd did not follow up with the initial reporter.They had already stated that the complaint occurred during testing and had not affected a patient.No other information was provided.(b)(4).

• Brand Name: ENTERALITE INFINITY ENTERAL FEEDING 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: 19983791
• Report Number: 1722139-2024-00432
• Device Sequence Number: 4431220
• Product Code: LZH
• UDI-Device Identifier: 10814844000327
• UDI-Public: 10814844000327
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 07/19/2024

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: INFKIT2
• Device Catalogue Number: INFKIT2
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2024
• Supplement Date Received by Manufacturer: 07/19/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown