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U.S. Department of Health and Human Services

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

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MOOG MEDICAL DEVICES GROUP ENTERALITE INFINITY ENTERAL FEEDING PUMP; ENTERAL INFUSION PUMP Back to Search Results
Model Number INFKIT2
Device Problem Insufficient Flow or Under Infusion (2182)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/02/2024
Event Type  malfunction  
Event Description
The initial reporter stated that the pump was not delivering the correct rate.They stated that the pump is programmed at 65 ml rate and 1170 ml dose, to deliver over 18 hours, between 4pm and 8am.They stated that the pump alarmed dose done in the middle of the night and there was approximately 400 ml formula left in the bag at that time.They did not state how long the pump had been infusing when this occurred or provided any other details.It's unclear if the pump infused at a rate that mmdg would consider reportable.Mmdg followed up with the initial reporter, who stated that they had received a replacement pump and the patient had not had any adverse effects due to the complaint.No other information was provided.(b)(4)],.
 
Manufacturer Narrative
The device was not returned to mmdg for investigation.A dhr review was completed and no non-conformances were found.Because the device was not returned to mmdg for evaluation, an investigation could not be completed.This report will be updated if the device is returned to mmdg.
 
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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 egelhoff
4314 zevex park lane
salt lake city, UT 84123
8012641001
MDR Report Key18608699
MDR Text Key335090795
Report Number1722139-2024-00067
Device Sequence Number1
Product Code LZH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K031199
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 01/02/2024
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 NumberINFKIT2
Device Catalogue NumberINFKIT2
Device Lot NumberN/A
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/02/2024
Initial Date FDA Received01/30/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/27/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age83 YR
Patient SexPrefer Not To Disclose
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