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

Model Number INFKIT2

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

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

Event Date 03/01/2016

Event Type  malfunction  

Manufacturer Narrative

The pump was returned to mmdg for evaluation, and subjected to visual, mechanical, and flow-related testing.The device's dhr and internal event log were also reviewed.The pump passed all tests, and was found to be performing according to specifications.No errors pertaining to the event as described by the initial reporter appeared in the event log, and the device's dhr showed no nonconformances.Mmdg is unable to replicate the complaint.

Event Description

The initial reporter stated that the pump acted as if it was running, but the bag was still full.The pump alarmed dose done as expected, but nothing was actually dispensed.No further information was provided.No indication of patient harm.(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: 5592849
• MDR Text Key: 43204556
• Report Number: 1722139-2016-00417
• 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: user facility
• Reporter Occupation: Service and Testing Personnel
• Type of Report: Initial
• Report Date: 04/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: INFKIT2
• Device Catalogue Number: INFKIT2
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2015
• 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