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

Model Number INFKIT2

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/25/2019

Event Type  malfunction  

Manufacturer Narrative

The pump was not returned to mmdg for evaluation.A dhr review was performed and found no issues during the original build.Because the pump was not returned mmdg was not able to investigate or confirm the complaint.Based in the complaint information provided, the pump seems to be infusing at a rate that mmdg would consider reportable.This report will be updated if the pump is returned to mmdg for this compliant.

Event Description

The initial reporter states " feeding is slowing down, leaving 150ml on the bag.Rate 89ml, dose 250ml.Delivering 100 to 150 ml less than it should.".Mmdg followed up with the initial reporter who stated that the patient did not have any adverse effects due to the complaint.(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 hardesty ; 4314 zevex park lane; salt lake city, UT 84123 ; 8012641001
• MDR Report Key: 8457296
• MDR Text Key: 140128365
• Report Number: 1722139-2019-00111
• 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: Nurse
• Type of Report: Initial
• Report Date: 02/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• 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
• Date Manufacturer Received: 02/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22 YR