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

Model Number INFKIT2

Device Problem Use of Device Problem (1670)

Patient Problem Aspiration/Inhalation (1725)

Event Date 06/29/2022

Event Type  Death  

Event Description

The initial reporter states that the patient passed away during the night.They stated that the patient used the pump at night for feedings at a rate of 55 ml/hr and a continuous dose.They suspected that the patient had aspirated and died.Mmdg did follow up with the initial reporter, but they did not provide any additional information about the event or the patients official cause of death.(b)(4).

Manufacturer Narrative

The device was returned to mmdg for evaluation.A dhr was completed and found no non-conformances.When the device was returned to mmdg for investigation, it operated as expected.There is no indication that the device malfunctioned.Based on the information provided to mmdg and the investigation, the pump appears to have performed as expected.This report is being filed out of an abundance of caution due to the patients death.

• 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: 15123069
• MDR Text Key: 296793586
• Report Number: 1722139-2022-00739
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 07/07/2022
• Date Manufacturer Received: 06/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 2 YR
• Patient Sex: Female