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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 Insufficient Flow or Under Infusion (2182)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/23/2020
Event Type  malfunction  
Manufacturer Narrative
The device was not returned to mmdg for evaluation.A dhr was performed and no non conformances were found.Because the device was not returned, mmdg has been unable to investigate or confirm the complaint.This report will be updated if the device is returned to mmdg.
 
Event Description
The initial reporter stated that the pump "stops feeding sporadically and does not complete dose".Mmdg followed up with the initial reporter who stated that they did not have any further information.(b)(4).
 
Event Description
The initial reporter stated that the pump "stops feeding sporadically and does not complete dose".Mmdg followed up with the initial reporter who stated that they did not have any further information.Complaint: (b)(4).
 
Manufacturer Narrative
The device was returned to mmdg for evaluation.A dhr was performed and no non conformances were found.When the device was returned to mmdg for investigation, the pump did under infuse, however, it was still within the volumetric range that mmdg would consider not reportable.Based on this information, no mdr would have been required.
 
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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
MDR Report Key9981635
MDR Text Key190186816
Report Number1722139-2020-00134
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 03/23/2020
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 Manufacturer04/22/2020
Initial Date Manufacturer Received 03/23/2020
Initial Date FDA Received04/21/2020
Supplement Dates Manufacturer Received03/23/2020
Supplement Dates FDA Received04/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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