CADD LEGACY 1 PUMP 6400 21-6400-51

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,distributor report with the FDA on 2020-03-31 for CADD LEGACY 1 PUMP 6400 21-6400-51 manufactured by Smiths Medical Asd, Inc..

Event Text Entries

[185924182] One cadd legacy 1 pump was returned for analysis. The event history log was reviewed and there was evidence of a 1871 error code. A functional check was performed and the pump was visually inspected. The reported error code 1871 was confirmed. The pump was found to be displaying "1871" error code message on power up during the investigation. The motor was found locked up not operable. The defective motor will be replaced to resolve the issue.
Patient Sequence No: 1, Text Type: N, H10


[185924183] Information was received indicating that a smiths medical cadd legacy 1 pump alarmed error 1871 during testing. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3012307300-2020-02552
MDR Report Key9908345
Report SourceCONSUMER,DISTRIBUTOR
Date Received2020-03-31
Date of Report2020-03-31
Date Mfgr Received2020-03-06
Device Manufacturer Date2006-12-26
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 ContactDAVE HALVERSON
Manufacturer Street6000 NATHAN LANE NORTH
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 LEGACY 1 PUMP
Generic NamePUMP, INFUSION
Product CodeFRN
Date Received2020-03-31
Returned To Mfg2020-03-09
Model Number6400
Catalog Number21-6400-51
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSMITHS MEDICAL ASD, INC.
Manufacturer Address6000 NATHAN LANE NORTH MINNEAPOLIS, MN US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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