CADD-MS3 AMBULATORY INFUSION PUMP 21-7411-51 7400

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 AMBULATORY INFUSION PUMP 21-7411-51 7400 manufactured by Smiths Medical Asd, Inc..

Event Text Entries

[185923059] Returned device was evaluated and the reported issue was unable to be verified. The software was replaced as a preventative measure. The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution. No issues were identified that would have impacted this event.
Patient Sequence No: 1, Text Type: N, H10


[185923060] Information was received indicating that a smiths medical cadd-ms3 ambulatory infusion pump lost its programming. There were no reported adverse events.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3012307300-2020-02478
MDR Report Key9908434
Report SourceDISTRIBUTOR
Date Received2020-03-31
Date of Report2020-03-31
Date Mfgr Received2020-03-03
Device Manufacturer Date2017-03-04
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 Street6000 NATHAN LANE NORTH
Manufacturer CityMINNEAPOLIS, MN
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCADD-MS3 AMBULATORY INFUSION PUMP
Generic NamePUMP, INFUSION
Product CodeFRN
Date Received2020-03-31
Returned To Mfg2020-03-11
Model Number21-7411-51
Catalog Number7400
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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