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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
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MOOG MEDICAL DEVICES GROUP ENTERALITE INFINITY ENTERAL FEEDING PUMP Back to Search Results
Model Number INFINITY PUMP
Device Problem Failure to Auto Stop (2938)
Patient Problem No Code Available (3191)
Event Date 12/05/2013
Event Type  malfunction  
Event Description
Mother alleged pump continued to run after the formula was gone.Dosage provided was 750 ml.There were no rate and patient impact reported.
 
Manufacturer Narrative
Pump has been tested several times using water, each time when bag was empty pump stopped pumping and alarming no food (or pump finish dose: alarming "dose done").All alarms have been checked and work properly.Complaint could not be duplicated.
 
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Brand Name
ENTERALITE INFINITY ENTERAL FEEDING PUMP
Manufacturer (Section D)
MOOG MEDICAL DEVICES GROUP
salt lake city UT
Manufacturer Contact
thanh quach, sr compl analyst
4314 zevex park lane
salt lake city, UT 84123
8012641001
MDR Report Key3883230
MDR Text Key4596647
Report Number1722139-2014-00050
Device Sequence Number1
Product Code LZH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K981816
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 01/23/2014
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 NumberINFINITY PUMP
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer02/13/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/23/2014
Initial Date FDA Received02/20/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/04/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
NEUTRIN JR/FIBER
Patient Age8 YR
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