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 Known Impact Or Consequence To Patient (2692)

Event Date 03/31/2020

Event Type  malfunction  

Manufacturer Narrative

This device was not returned to mmdg for evaluation.A dhr review was completed and found no non-conformances associated with the device.Because the pump was not returned, mmdg was unable to investigate the complaint.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 did not alarm when formula had run out.They stated that the pump had continued to run after the formula ran out and did not alarm, that they would find the tubing "full of air" and were unsure if the air had reached the patient.Mmdg did follow up with the initial reporter who stated that the patient did not have any adverse effects due to the complaint.They did not provide any further information about the complaint.(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
• Manufacturer (Section G): MOOG MEDICAL DEVICES GROUP; 4314 zevex park lane; salt lake city, ut
• Manufacturer Contact: kristin hardesty ; 4314 zevex park lane; salt lake city, ut ; 2641001112
• MDR Report Key: 10006383
• MDR Text Key: 190768919
• Report Number: 1722139-2020-00151
• 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: 03/31/2020

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2020
• Initial Date FDA Received: 04/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2016
• 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