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

Model Number INFKIT2

Device Problem Failure to Auto Stop (2938)

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

Event Date 09/02/2021

Event Type  malfunction  

Manufacturer Narrative

This device was returned to mmdg for evaluation.A dhr review was completed and found no non-conformances.When the device was returned to mmdg for investigation, the reported complaint could not be replicated or confirmed, however, the pcb had failed, which resulted in the no flow out alarm failing.This report is being filed because the event occurred while the device was in use by a pediatric patient.Per our procedures all reports of this type of event that involve a pediatric patient are considered reportable.

Event Description

The initial reporter stated that the pump "didn't sense when feed done".They stated that the rate was set to 375 ml/hr and the dose was set to 400 ml.When the pump was returned to mmdg for investigation, the reported complaint could not be replicated or confirmed.There was no indication that the complaint occurred as reported.During the investigation at mmdg the no flow out alarm failed to alarm.The initial reporter stated that the patient had not experienced any adverse effects due to the complaint, but that they had no further information.(b)(4).

• 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: 12537256
• MDR Text Key: 273576436
• Report Number: 1722139-2021-00704
• 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: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• 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: 09/24/2021
• Date Manufacturer Received: 09/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2018
• 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: 4 YR