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

Model Number INFKIT2

Device Problem Protective Measures Problem (3015)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2019

Event Type  malfunction  

Manufacturer Narrative

The pump was not returned to mmdg for evaluation.A service call review was performed and found no related issues during the pump's last servicing.Because the pump was not returned mmdg was not able to investigate or confirm the complaint.This report is being filed for the reported delay in therapy.

Event Description

The initial reporter stated that the pump alarmed an error code 12.They also stated that turning the pump off and back on again did not resolve the error code 12.Mmdg followed up with the initial reporter who stated that the pump was replaced, but the patient experienced a 36 hour delay as they did not have syringe bolus supplies to supplement with.The patient is able to eat by mouth, but this method is not tolerated well.The initial reporter also stated there was no harm to patient.(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: ariann dalton ; 4314 zevex park lane; salt lake city, UT 84123 ; 8012641001
• MDR Report Key: 9535232
• MDR Text Key: 174179673
• Report Number: 1722139-2019-00423
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• 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?: No
• Date Manufacturer Received: 12/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2008
• 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
• Patient Age: 3 YR