MAUDE Adverse Event Report: MOOG MEDICAL DEVICES GROUP ENTERALITE INFINITY EFPKIT, PUMP ONLY, N AMER,; ENTERAL INFUSION PUMP

Model Number INFP01

Device Problems Device Alarm System (1012); Device Displays Incorrect Message (2591)

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

Event Date 10/05/2015

Event Type  malfunction  

Manufacturer Narrative

The complainant returned the device for evaluation.After several flow and mechanical tests, mmdg was unable to duplicate the complaint, which remains unconfirmed.This mdr is being submitted because the reported overrun event involved a pediatric patient.

Event Description

The initial reporter stated: "pumped air all the way to patient with no alarm".During a follow-up conversation, the initial reported stated that the pump is cleaned weekly and sensors have been wiped off in between.Mmdg's representative discussed with the provider setting the dose for the amount put into feeding bag instead of inf to prevent air being pumped if pump does not sense no food.No further information was provided, and no injury to a patient was reported.[(b)(4)].

• Brand Name: ENTERALITE INFINITY EFPKIT, PUMP ONLY, N AMER,
• 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: 5357419
• MDR Text Key: 35998711
• Report Number: 1722139-2016-00062
• 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: Other
• Type of Report: Initial
• Report Date: 10/29/2015

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: INFP01
• Device Catalogue Number: INFP01
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/29/2015
• Initial Date FDA Received: 01/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2010
• 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
• Patient Age: 6 YR
• Patient Weight: 20