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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MOOG MEDICAL DEVICES GROUP ENTERALITE INFINITY ADMINISTRATION SET; ENTERAL INFUSION PUMP
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MOOG MEDICAL DEVICES GROUP ENTERALITE INFINITY ADMINISTRATION SET; ENTERAL INFUSION PUMP Back to Search Results
Model Number INF0500
Device Problems Defective Alarm (1014); Failure to Infuse (2340)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/01/2016
Event Type  malfunction  
Manufacturer Narrative
The device in question was not returned to mmdg for evaluation.Mmdg is unable to verify the veracity of the complaint or otherwise evaluate the device.A review of the device's dhr shows all acceptance records present and no non-conformances.
 
Event Description
The initial reporter stated that the pump "runs without alarming but nothing dispenses".They also gave the additional detail that the pump runs and says it is delivering formula but the bag will be full in the morning after night feed.It was indicated that the device is being used on a patient, but the initial reporter provided no details about the patient.(b)(4).
 
Manufacturer Narrative
A device from the same lot was returned to mmdg for evaluation.Mmdg is was unable to replicate or confirm the complaint.A review of the device's dhr shows all acceptance records present and no non-conformances.
 
Event Description
The initial reporter stated that the pump "runs without alarming but nothing dispenses".They also gave the additional detail that the pump runs and says it is delivering formula but the bag will be full in the morning after night feed.It was indicated that the device is being used on a patient, but the initial reporter provided no details about the patient.(b)(4).
 
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Brand Name
ENTERALITE INFINITY ADMINISTRATION SET
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, SRL
coyol free zone and
business park
alajuela, san jose 20113
CS   20113
Manufacturer Contact
kristin hardesty
4314 zevex park lane
salt lake city, UT 84123
8012641001
MDR Report Key5618365
MDR Text Key43994123
Report Number1722139-2016-00427
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 user facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 04/28/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date12/23/2018
Device Model NumberINF0500
Device Catalogue NumberINF0500
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/05/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/29/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/23/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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