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

Model Number INFKIT2

Device Problem Insufficient Flow or Under Infusion (2182)

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

Event Date 04/21/2020

Event Type  malfunction  

Manufacturer Narrative

This device was returned to mmdg for evaluation.Based on the original complaint information, there was no indication of a reportable malfunction.During the investigation the pump under infused at a rate that mmdg considers reportable.The rotor assembly pins were misaligned, which caused the under infusion.

Event Description

The initial reporter stated that the pump had cosmetic damages.They stated that this occurred during testing and did not effect on a patient.When the pump was returned to mmdg for investigation it was found that the pump was infusing at a rate that mmdg considers reportable.(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
• Manufacturer (Section G): MOOG MEDICAL DEVICES GROUP; 4314 zevex park lane; salt lake city, ut
• Manufacturer Contact: kristin hardesty ; 4314 zevex park lane; salt lake city, ut ; 2641001112
• MDR Report Key: 9990392
• MDR Text Key: 190192127
• Report Number: 1722139-2020-00139
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 04/07/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/21/2020
• Initial Date FDA Received: 04/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1