MAUDE Adverse Event Report: MOOG MEDICAL DEVICES GROUP BAG SET, 500ML, ENTERALITE; ENTERAL FEEDING SET

Model Number INF0500

Device Problems Failure to Sense (1559); Failure to Infuse (2340)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/02/2014

Event Type  malfunction  

Manufacturer Narrative

The complainant returned the device for evaluation to moog medical devices group (mmdg) in utah.Mmdg sent the device via fedex to moog medical devices group, srl in costa rica.During transit the devices were inadvertently lost.

Event Description

Customer states: care giver states the inf0500 sets with lot # cf1401704 are pumping air and not letting formula go through but air only, pump does not alarm.Care giver will change the set and the feeding will be completed without problems.Three pumps have been exchanged and all three have passed the rapid check procedure test, sn (b)(4), this last pump was tested and passed test before it was given to the patient.Customer would like an investigation as believed to be users error because pumps pass all testing without problems.Pumps are now with other patients after passing all testing and the pumps are working with no problems at all.(b)(4).

• Brand Name: BAG SET, 500ML, ENTERALITE
• Type of Device: ENTERAL FEEDING SET
• Manufacturer (Section D): MOOG MEDICAL DEVICES GROUP; 4314 zevex park lane; salt lake city UT 84123
• Manufacturer (Section G): MOOG MEDICAL DEVICES GROUP, SRL; coyol free zone and; business park; alajuela, san jose 20113 ; CS 20113
• Manufacturer Contact: matt brinkerhoff ; 4314 zevex park lane; salt lake city, UT 84123 ; 8012641001
• MDR Report Key: 5503118
• MDR Text Key: 40390370
• Report Number: 1722139-2016-00367
• Device Sequence Number: 1
• Product Code: PIO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142539
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Caregivers
• Device Expiration Date: 01/17/2014
• Device Model Number: INF0500
• Device Catalogue Number: INF0500
• Device Lot Number: CF1401704
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NEOCATE JR
• Patient Age: 2 YR
• Patient Weight: 12