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

Model Number INFKIT2

Device Problem Protective Measures Problem (3015)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/10/2024

Event Type  malfunction  

Manufacturer Narrative

The device was returned to mmdg for investigation.A dhr review was completed and no non-conformances were found.When the device was returned to mmdg for investigation, the pump alarms operated as expected and were observed visually, however the pump was not able to alarm audibly as a result of the speaker failing.The pump was serviced to correct the issue.

Event Description

The initial reporter stated that the pump alarms did not work.They stated that the pump made no audible alarm sound.Mmdg did follow up with the initial reporter who stated that the complaint had occurred during testing and had not had any effect on a patient.(b)(4).

• Brand Name: ENTERALITE INFINITY ENTERAL FEEDING 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: kristin egelhoff ; 4314 zevex park lane; salt lake city, UT 84123 ; 8012641001
• MDR Report Key: 18652320
• MDR Text Key: 334884655
• Report Number: 1722139-2024-00096
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• 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: 01/24/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1