MAUDE Adverse Event Report: MOOG MEDICAL DEVICES GROUP ENTERALITE INFINITY ORANGE ENTERAL FEEDING PUMP; 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	11/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pump was not returned to mmd for evaluation.A dhr review was not completed because the device serial number was not provided.Because the device was not returned to mmd, an investigation could not be completed.This report is being filed for the reported delay in therapy that the patient experienced as a result of the complaint.
Event or Problem Description
The initial reporter stated that the pump was alarming, but that they could not read anything on the screen.They stated that formula had been spilled on the pump, and they could see it inside the pump screen.They stated that this resulted in a six hour delay of therapy and that they were not able to complete the feeding via gravity because the patient did not tolerate it.Mmd did follow up with the initial reporter, who stated that the patient did not have any adverse effects due to the complaint, that the pump had been replaced, that they could not provide the pump serial number, and had no other information to provide.[ (b)(6) ].

• Brand Name: ENTERALITE INFINITY ORANGE 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: 20884473
• Report Number: 1722139-2024-00666
• Device Sequence Number: 8710006
• Product Code: LZH
• UDI-Device Identifier: 10814844000334
• UDI-Public: 10814844000334
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 11/13/2024

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2024
• Initial Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Prefer Not To Disclose