CADD MS3 GRAY SLATE 7400 21-7411-51

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-31 for CADD MS3 GRAY SLATE 7400 21-7411-51 manufactured by Smiths Medical Asd,inc.

Event Text Entries

[185923430] Investigation completed on a smith medical cadd ms3 pump alarming could not be verified during testing. The software was replaced as a preventive measure; s127 c000 r000. No fault found. A dhr review was performed subsequent to the manufacturing of the device and prior to its release. No problems or issues were identified during this dhr review.
Patient Sequence No: 1, Text Type: N, H10


[185923431] ?information received a smiths medical cadd ms3 gray slate pump is alarming . no patient adverse events reported .
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3012307300-2020-02443
MDR Report Key9908324
Report SourceDISTRIBUTOR
Date Received2020-03-31
Date of Report2020-03-31
Date Mfgr Received2020-03-03
Device Manufacturer Date2016-10-18
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
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactDAVE HALVERSON
Manufacturer Street6000 LANE N
Manufacturer CityMINNEAPOLIS, MN
Manufacturer CountryUS
Manufacturer Phone3833310
Manufacturer G1SMITHS MEDICAL ASD, INC.
Manufacturer Street3350 GRANADA AVENUE NORTH, SUITE 100
Manufacturer CityOAKDALE, MN
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCADD MS3 GRAY SLATE
Generic NamePUMP, INFUSION
Product CodeFRN
Date Received2020-03-31
Returned To Mfg2020-03-10
Model Number7400
Catalog Number21-7411-51
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSMITHS MEDICAL ASD,INC
Manufacturer Address6000 LANE N MINNEAPOLIS, MN US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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