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

[185904297] One cadd legacy 1 pump was returned for analysis. The event history log was reviewed and there was no evidence of the reported issue. Three separate delivery accuracy tests were performed and the pump was visually inspected. The reported issue was unable to be confirmed. Delivery accuracy testing found the pumps average delivery error to be within the published specification of +/-6%. However, fluid ingressions were found on the pump by the chassis base of the expulsor, valves and occlusion sensors. The "failed accuracy -9. 65%" issue was possibly caused by fluid ingressions that damaged the gasket. It was recommend that the expulsor assembly be replaced as a preventative measure.
Patient Sequence No: 1, Text Type: N, H10


[185904298] Information was received indicating that a smiths medical cadd legacy 1 pump failed accuracy by -9. 65% during testing. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3012307300-2020-02549
MDR Report Key9908365
Report SourceCONSUMER,DISTRIBUTOR
Date Received2020-03-31
Date of Report2020-03-31
Date Mfgr Received2020-03-06
Device Manufacturer Date2003-04-28
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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