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

Model Number FLOCARE INFINITY

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 06/02/2014

Event Type  Death  

Manufacturer Narrative

Although the flocare infinity enteral pump is manufactured exclusively for export to nutricia, a firm located in the united kingdom, and is not distributed in the united states, mmdg is submitting this mdr based on the similarity in the design and manufacture of flocare infinity and enteralite infinity pumps.The investigation done by the british police department in worcestershire shows that no abnormality was found in the device.The device has not yet been returned to the manufacturer, so a proper evaluation of the cause of the leak has not yet been possible.Moog will update this report with new information as it becomes available.Device not returned to manufacturer.

Event Description

The death of an infant was reported to nutricia because at the time of the event a flocare infinity pump was being used to feed the infant in the infant's home.Nutricia subsequently reported the event to mmdg.(b)(4).

• Brand Name: FLOCARE INFINITY
• 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: 5485022
• MDR Text Key: 39843980
• Report Number: 1722139-2016-00156
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: AF
• PMA/PMN Number: N/A-FOREIGN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Patient Family Member or Friend
• Device Model Number: FLOCARE INFINITY
• Device Catalogue Number: 26514-002
• Device Lot Number: NOT PROVIDED
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2007
• 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 Outcome(s): Death
• Patient Age: 6 MO