CADD-LEGACY DUODOPA AMBULATORY INFUSION PUMP 1400 21-1400-03

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-LEGACY DUODOPA AMBULATORY INFUSION PUMP 1400 21-1400-03 manufactured by Smiths Medical Asd, Inc..

Event Text Entries

[185740142] Information was received indicating that a smiths medical cadd-legacy duodopa ambulatory infusion pump was "accidentally programmed and saved the continuous day rate to 4. 5 ml/h instead of 2. 1ml/h in the morning when switching from night to day rate. " it was reported that the nursing staff was subsequently trained. No adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3012307300-2020-02582
MDR Report Key9903702
Report SourceDISTRIBUTOR
Date Received2020-03-31
Date of Report2020-03-31
Date Mfgr Received2020-03-03
Device Manufacturer Date2017-10-17
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 AVE. N. SUITE 100
Manufacturer CityOAKDALE, MN
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCADD-LEGACY DUODOPA AMBULATORY INFUSION PUMP
Generic NamePUMP, INFUSION, ENTERAL
Product CodeLZH
Date Received2020-03-31
Model Number1400
Catalog Number21-1400-03
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
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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