MAUDE Adverse Event Report: MOOG MEDICAL DEVICES GROUP INFINITY 1200 ML ENTERAL PUMP DELIVERY SET WITH ENFIT CONNECTOR; ENTERAL FEEDING SET

Model Number	INF1200-E
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to mmdg for evaluation.A dhr review could not be completed because no lot number was provided.Because the device was not returned to mmdg, an investigation could not be completed.This report is being filed for the reported delay of therapy the patient experienced.
Event or Problem Description
The initial reporter stated that the infinity feeding bags would often not prime and were causing persistent no flow alarms.They stated that they had the pump replaced and the issue continued, and that they found the pump alarming no flow and that the "majority of the feeding remained in the bag" and that this caused the patient to miss that feeding overnight.They also stated that they're using a formula that is blenderized and this is cautioned against in the infinity manual.Mmdg did follow up with the initial reporter to obtain additional information, however, those attempts were unsuccessful.They had stated that there was no harm caused to the patient by the delay.No other information was provided.Complaint-(b)(4).
Event or Problem Description
The initial reporter stated that the infinity feeding bags would often not prime and were causing persistent no flow alarms.They stated that they had the pump replaced and the issue continued, and that they found the pump alarming no flow and that the "majority of the feeding remained in the bag" and that this caused the patient to miss that feeding overnight.They also stated that they're using a formula that is blenderized and this is cautioned against in the infinity manual.Mmdg did follow up with the initial reporter to obtain additional information, however, those attempts were unsuccessful.They had stated that there was no harm caused to the patient by the delay.No other information was provided.[complaint (b)(4)].
Additional Manufacturer Narrative
The device was returned to mmdg for evaluation.A dhr review could not be completed because no lot number was provided.When the suspected devices were returned to mmd, they operated as expected.Mmd could not replicate or confirm the reported complaint.This report is being filed for the reported delay of therapy the patient experienced.

• Brand Name: INFINITY 1200 ML ENTERAL PUMP DELIVERY SET WITH ENFIT CONNECTOR
• Common Device Name: ENTERAL FEEDING SET
• Manufacturer (Section D): MOOG MEDICAL DEVICES GROUP; 4314 zevex park lane; salt lake city UT 84123
• Manufacturer (Section G): MOOG MEDICAL DEVICES GROUP, SRL; coyol free zone and; business park; alajuela, cri 20113 ; CS 20113
• Manufacturer Contact: kristin egelhoff ; 4314 zevex park lane; salt lake city, UT 84123 ; 8012641001
• MDR Report Key: 19071995
• Report Number: 1722139-2024-00180
• Device Sequence Number: 6826082
• Product Code: PIO
• UDI-Device Identifier: 10814844001959
• UDI-Public: 10814844001959
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K031199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: INF1200-E
• Device Catalogue Number: INF1200-E
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2024
• Supplement Date Received by Manufacturer: 03/12/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 4 YR
• Patient Sex: Prefer Not To Disclose