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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 11/08/2017
Event Type  malfunction  
Manufacturer Narrative
This device was not returned to mmdg for evaluation.Because the pump was not returned an investigation was not possible.A dhr review was completed and found no non-conformances associated with the device.Because a rate and dose is being set while the pump is in use, the pump cannot overrun and pump air to the patient unless the user is not putting enough formula in the feeding set.The amount of formula being added to the set was not reported to mmdg.The bags also state on the label that they should only be used for 24 hours.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 is delivering air to patient after the bag empties.She states that the pump does not alarm and continues to pump air to the patient.Mmdg did follow up with the initial reporter, who stated that the patient had received a replacement pump and was "okay" after the complaint occurred.(b)(4).
 
Manufacturer Narrative
The device was returned to mmdg for evaluation.A dhr review was completed and found no non-conformances during the original build.When the pump was returned to mmdg for investigation, it operated as expected.Mmdg could not replicate or confirm the complaint.There is no indication that the complaint occurred as reported.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 is delivering air to patient after the bag empties.She states that the pump does not alarm and continues to pump air to the patient.Mmdg did follow up with the initial reporter, who stated that the patient had received a replacement pump and was "okay" after the complaint occurred.(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
Manufacturer (Section G)
MOOG MEDICAL DEVICES GROUP
4314 zevex park lane
salt lake city UT 84123
Manufacturer Contact
kristin hardesty
4314 zevex park lane
salt lake city, UT 84123
8012641001
MDR Report Key7110683
MDR Text Key94667927
Report Number1722139-2017-00193
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/13/2017
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? Device Returned to Manufacturer
Date Returned to Manufacturer11/17/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/13/2017
Initial Date FDA Received12/12/2017
Supplement Dates Manufacturer Received11/13/2017
Supplement Dates FDA Received12/16/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/17/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Age16 MO
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