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

Model Number INFKIT2

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/02/2019

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.This report was filed for the reported delay in therapy that the patient experienced.

Event Description

The initial reporter stated that the pump was making a clicking noise when it was running.They did not specify is this stopped the pump from infusing.The initial reporter also stated that they were provided with a new pump, and that they were able to do gravity feedings during the day, but that they did not use this method at night, resulting in three nights of missed feedings.No adverse effect to the patient was reported.(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: 8859524
• MDR Text Key: 153255195
• Report Number: 1722139-2019-00243
• 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: health professional
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2019
• 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
• Date Manufacturer Received: 07/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 10 YR