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U.S. Department of Health and Human Services

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

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MOOG MEDICAL DEVICES GROUP ENTERALITE INFINITY ENTERAL INFUSION PUMP Back to Search Results
Model Number INFKIT2
Device Problem Insufficient Flow or Under Infusion (2182)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/18/2020
Event Type  malfunction  
Manufacturer Narrative
The device was not returned to mmdg for evaluation.A dhr was performed and no non conformances were found.Because the device was not returned, mmdg has been unable to investigate or confirm the complaint.This report will be updated if the device is returned to mmdg.
 
Event Description
The initial reporter stated that the pump was not delivering accurately.They stated that it was under delivering.Mmdg followed up with the initial reporter who stated that the patient did not have any adverse effects due to the complaint, and that they did not have any further information.(b)(4).
 
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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
Manufacturer (Section G)
MOOG MEDICAL DEVICES GROUP
4314 zevex park lane
salt lake city, ut
Manufacturer Contact
kristin hardesty
4314 zevex park lane
salt lake city, ut 
2641001112
MDR Report Key10272724
MDR Text Key199681473
Report Number1722139-2020-00301
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 06/18/2020
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 06/18/2020
Initial Date FDA Received07/14/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/19/2020
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 Age3 MO
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