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

Model Number INFKIT2

Device Problem Protective Measures Problem (3015)

Patient Problem Missed Dose (2561)

Event Date 04/01/2016

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to mmdg for evaluation.Because the actual device could not be inspected, mmdg has been unable to confirm the complaint.A serial number was not provided, no device history could be reviewed.

Event Description

The initial reporter stated that the pump alarmed an error code 10.They were unable to resolve the error code alarm.They did request a replacement pump, in waiting for the replacement the patient went without feeds for 48 hours.The user's feeds were disrupted for 48 hours.They were able to continue with flushes and medications as scheduled.The initial reporter indicated that there were no adverse effects and that the patient was doing well at the time of the follow up.(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: chris dodge ; 4314 zevex park lane; salt lake city, UT 84123 ; 8012641001
• MDR Report Key: 5683585
• MDR Text Key: 46070034
• Report Number: 1722139-2016-00460
• 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: 05/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2016
• Is this an Adverse Event Report?: No
• 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
• Date Manufacturer Received: 04/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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