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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 Failure to Auto Stop (2938)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/14/2019
Event Type  malfunction  
Manufacturer Narrative
This device was not returned to mmdg for evaluation.A dhr review was completed and found no non-conformances associated with the device.Because the pump was not returned, mmdg was unable to investigate the complaint.This report is being filed because the event occurred while the device was in use by a pediatric patient.Per our procedures all reports of this type of event that involve a pediatric patient are considered reportable.
 
Event Description
The initial reporter stated that the pump was continuing to run and pumping air after formula had run out.Mmdg did follow up with the initial reporter who stated that the patient did not have any adverse effects due to the complaint.They did not provide any further information about the complaint.(b)(4).
 
Manufacturer Narrative
This device was returned to mmdg for evaluation.A dhr review was completed and no non-conformances were found.When the device was returned to mmdg for investigation, it operated as expected.The pump history was also reviewed.The pump history could support the reported complaint.Mmdg could not replicate or confirm the reported complaint.
 
Event Description
The initial reporter stated that the pump was continuing to run and pumping air after formula had run out.Mmdg did follow up with the initial reporter who stated that the patient did not have any adverse effects due to the complaint.They did not provide any further information about the complaint.(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 84123
MDR Report Key10267898
MDR Text Key198946604
Report Number1722139-2020-00296
Device Sequence Number1
Product Code LZH
Combination Product (y/n)N
PMA/PMN Number
K031199
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 06/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2020
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? Device Returned to Manufacturer
Date Returned to Manufacturer07/15/2020
Date Manufacturer Received06/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Age11 YR
Patient Weight23
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