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

Model Number INF1200

Device Problems Defective Alarm (1014); Failure to Infuse (2340)

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

Event Date 04/29/2016

Event Type  malfunction  

Manufacturer Narrative

The device in question was not returned to mmdg for evaluation.Mmdg is unable to verify the veracity of the complaint or otherwise evaluate the device.A review of the device's dhr shows all acceptance records present and no non-conformances.

Event Description

The initial reporter stated that the pump "runs without alarming but nothing dispenses." they also gave the additional detail that the pump runs during the morning feed, but when the afternoon feed is started the pump appears to be running, but nothing moves through the tubing.It was indicated that the device is being used on a patient, but the initial reporter provided no details about the patient.(b)(4).

• Brand Name: ENTERALITE INFINITY ADMINISTRATION SET
• 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, 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: 5701494
• MDR Text Key: 46669603
• Report Number: 1722139-2016-00468
• 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: Other Caregivers
• Type of Report: Initial
• Report Date: 06/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: INF1200
• Device Catalogue Number: INF1200
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2015
• 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