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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; ENTERAL INFUSION PUMP

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MOOG MEDICAL DEVICES GROUP ENTERALITE INFINITY ENTERAL FEEDING PUMP; ENTERAL INFUSION PUMP Back to Search Results
Model Number INFKIT2
Device Problem Excess Flow or Over-Infusion (1311)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/19/2022
Event Type  malfunction  
Manufacturer Narrative
The pump was not returned to mmdg for evaluation.A dhr review was completed and found no non-conformances.Because the device was not returned to mmdg, no investigation could be completed.This report will be updated if the device is returned to mmdg.
 
Event Description
The initial reporter stated that the pump was not delivering correctly.They stated that it was both over and under, but that it was not accurate.The rate, dose, and amount delivered that they provided indicates that the pump may have infused at a rate that mmdg would consider reportable.Mmdg did follow up with the initial reporter, who stated that the patient had not experienced any adverse effects due to the complaint.No other information was provided.(b)(4).
 
Manufacturer Narrative
The pump was returned to mmdg for evaluation.A dhr review was completed and found no non-conformances.When the device was returned to mmdg for investigation, it operated as expected.Mmdg could not replicate or confirm the reported complaint.Based on this information, no mdr would have been required.
 
Event Description
The initial reporter stated that the pump was not delivering correctly.They stated that it was both over and under, but that it was not accurate.The rate, dose, and amount delivered that they provided indicates that the pump may have infused at a rate that mmdg would consider reportable.Mmdg did follow up with the initial reporter, who stated that the patient had not experienced any adverse effects due to the complaint.No other information was provided.(b)(4).
 
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Brand Name
ENTERALITE INFINITY ENTERAL FEEDING 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 egelhoff
4314 zevex park lane
salt lake city, UT 84123
8012641001
MDR Report Key14690422
MDR Text Key294515544
Report Number1722139-2022-00585
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,Followup
Report Date 05/19/2022
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
Initial Date Manufacturer Received 05/19/2022
Initial Date FDA Received06/14/2022
Supplement Dates Manufacturer Received05/19/2022
Supplement Dates FDA Received06/16/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/28/2022
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 Age74 YR
Patient SexFemale
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