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

Model Number INFP01

Device Problem Failure to Fire (2610)

Patient Problem Dehydration (1807)

Event Date 05/01/2015

Event Type  malfunction  

Manufacturer Narrative

The device was returned to mmdg for evaluation.A visual inspection and several alarm, error, and volumetric accuracy tests were performed.The pump's front housing had been damaged, usually indicative of the pump having experienced a shock, such as dropping on to a hard surface.The damage to the housing was found to be causing the errors described in the complaint.The device was repaired and returned to the distributor.This is a retrospective filing.It is being submitted today because the therapy delay experienced by the patient required a visit to a medical facility.

Event Description

As recorded by customer service: "pump does not alarm no flow in.Looks like its running but no food is being fed.Mother states that because her daughter is not receiving food this has caused dehydration and had to take to dr to rehydrate." during a follow-up call with the mother, mmdg clinical learned that the daughter had recovered, and that the family had received a new, working pump.No further information was provided.(b)(4).

• Brand Name: ENTRALITE 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: 5415517
• MDR Text Key: 37619503
• Report Number: 1722139-2016-00122
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042228
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 06/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Patient Family Member or Friend
• 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: 06/08/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2013
• 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 Outcome(s): Required Intervention
• Patient Age: 2 YR
• Patient Weight: 10