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

Model Number INFKIT2

Device Problem Failure to Auto Stop (2938)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/11/2022

Event Type  malfunction  

Event Description

The initial reporter stated that the pump under infused and that it also did not stop when it was done.They stated that it was pumping air.Mmdg did follow up with the initial reporter to obtain addition information.The initial reporter stated that the patient did not experience any adverse effects due to the complaint.(b)(4).

Manufacturer Narrative

This device was not returned to mmdg for evaluation.A dhr review was completed and found no non-conformances.Because the device was not returned to mmdg, no investigation could be completed.This report will be updated if the device is returned to mmdg.This report is being filed because there is indication that the event occurred while the device was in use by a pediatric patient (under 18).Per our procedures all reports of this type of event that involve a pediatric patient are considered reportable.

Manufacturer Narrative

This device was returned to mmdg for evaluation.A dhr review was completed and found no non-conformances.When the device was returned to mmdg for investigation, it operated as expected.Mmdg could not replicate or confirm the reported complaint.This report is being filed because there is indication that the event occurred while the device was in use by a pediatric patient (under 18).Per our procedures all reports of this type of event that involve a pediatric patient are considered reportable.

Event Description

The initial reporter stated that the pump under infused and that it also did not stop when it was done.They stated that it was pumping air.Mmdg did follow up with the initial reporter to obtain addition information.The initial reporter stated that the patient did not experience any adverse effects due to the complaint.[complaint- (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 84123
• Manufacturer (Section G): MOOG MEDICAL DEVICES GROUP; 4314 zevex park lane; salt lake city UT 84123
• Manufacturer Contact: kristin egelhoff ; 4314 zevex park lane; salt lake city, UT 84123 ; 8012641001
• MDR Report Key: 14340408
• MDR Text Key: 291304624
• Report Number: 1722139-2022-00483
• 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,Followup
• Report Date: 04/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 5 YR
• Patient Sex: Female
• Patient Weight: 13 KG