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

Model Number INFKIT2

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Feeding Problem (1850)

Event Date 01/20/2016

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to mmdg for evaluation.Confirmation of the complaint and investigation has not been possible.A review of the device history record showed no noncomformances during the manufacture of the involved pump.

Event Description

The initial reporter stated that the pump experienced an error, and that it would not turn off or respond.During a follow-up call with the initial reporter, moog clinical learned that the patient had scheduled the drop-off of a new pump from the provider.Mmdg also learned that it had been several hours since first encountering the error, resulting in the patient experiencing a long delay of feeding.No injury to the patient as a result of this event has been 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: matt brinkerhoff ; 4314 zevex park lane; salt lake city, UT 84123 ; 8012641001
• MDR Report Key: 5455935
• MDR Text Key: 38856314
• Report Number: 1722139-2016-00130
• 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: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 01/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Patient Family Member or Friend
• 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?: No
• Initial Date Manufacturer Received: 01/25/2016
• Initial Date FDA Received: 02/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: PEDIASURE 1.5
• Patient Outcome(s): Other
• Patient Age: 7 YR
• Patient Weight: 16