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

Model Number INFKIT2

Device Problem Device Issue (2379)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/11/2017

Event Type  malfunction  

Manufacturer Narrative

The device was returned to mmdg for evaluation.An investigation was conducted but mmdg was unable to confirm or replicate the complaint.The pump log was reviewed and a "no flow" alarm occurence was noted.The initial reporter did state that the patient experienced a delay in therapy and missed a feeding, but they also stated that a replacement pump was delivered within two hours.Mmdg did follow up with the initial reporter to try and clarify how long the patients feeding was delayed, but no other information was available.This report is being filed for the delay in therapy the patient experienced.

Event Description

The initial reporter states that the pump would not deliver formula.They also stated that this resulted in the patient missing their overnight feeding.During a follow up from mmdg the initial reporter stated that the patient missed the overnight feeding, but that a replacement pump was delivered within two hours.They also stated that the patient was doing fine after the event.(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: kristin hardesty ; 4314 zevex park lane; salt lake city, UT 84123 ; 8012641001
• MDR Report Key: 6640489
• MDR Text Key: 77633254
• Report Number: 1722139-2017-00088
• 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: 05/15/2017

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: 06/01/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/15/2017
• Initial Date FDA Received: 06/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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: N
• Patient Sequence Number: 1
• Patient Age: 2 YR