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

Model Number INFKIT2

Device Problem Protective Measures Problem (3015)

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

Event Date 12/07/2023

Event Type  malfunction  

Event Description

The initial reporter stated that the pump was pumping air after the formula was gone.They also stated that the pump would sometimes over infuse and other times it would under infuse.They stated that the pump rate was 600 ml/hr and that the dose was infinity, but they did not provide any information about the amount of formula they were adding to the bag during each feeding and how long they expected the feeding to take.Mmdg followed up with the initial reporter to try and obtain additional information about the complaint.They stated that there had been no adverse effect to the patient, but that they had no further information.(b)(4).

Manufacturer Narrative

This device was returned to mmdg for evaluation.A dhr review was completed and no non-conformances were found.When the device was returned to mmdg for investigation, the pump operated as expected.The pump log also showed multiple no food alarms that had occurred.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.

• Brand Name: ENTERALITE INFINITY ENTERAL INFUSION 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: 18739561
• MDR Text Key: 336855380
• Report Number: 1722139-2024-00113
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/22/2024

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
• 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: 02/01/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2024
• Initial Date FDA Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 7 YR
• Patient Sex: Prefer Not To Disclose