ENTERALITE INFINITY ENTERAL FEEDING PUMP INFKIT2

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-31 for ENTERALITE INFINITY ENTERAL FEEDING PUMP INFKIT2 manufactured by Moog Medical Devices Group.

Event Text Entries

[185900353] The device was not returned to mmdg for evaluation. A dhr was performed and found no nonconformances. 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.
Patient Sequence No: 1, Text Type: N, H10


[185900414] The initial reporter states that the pump appeared to be running, but was not delivering. They stated that there were no alarms. Mmdg followed up with the initial reporter, who stated that the patient had experienced a delay in therapy, but had not had any adverse effects due to the complaint. (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1722139-2020-00110
MDR Report Key9904553
Report SourceUSER FACILITY
Date Received2020-03-31
Date of Report2020-03-04
Date of Event2020-03-04
Date Mfgr Received2020-03-04
Device Manufacturer Date2018-02-14
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKRISTIN HARDESTY
Manufacturer Street4314 ZEVEX PARK LANE
Manufacturer CitySALT LAKE CITY, UT
Manufacturer CountryUS
Manufacturer Phone2641001112
Manufacturer G1MOOG MEDICAL DEVICES GROUP
Manufacturer Street4314 ZEVEX PARK LANE
Manufacturer CitySALT LAKE CITY, UT
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameENTERALITE INFINITY ENTERAL FEEDING PUMP
Generic NameENTERAL INFUSION PUMP
Product CodeLZH
Date Received2020-03-31
Model NumberINFKIT2
Catalog NumberINFKIT2
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMOOG MEDICAL DEVICES GROUP
Manufacturer Address4314 ZEVEX PARK LANE SALT LAKE CITY, UT US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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