DUODOPA PUMP 1400 21-1400-175

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,distributor,other report with the FDA on 2020-03-14 for DUODOPA PUMP 1400 21-1400-175 manufactured by Smiths Medical Asd,inc.

Event Text Entries

[183473744] Investigation completed on a smiths medical duodpa pump. The ehl history revealed alarm of lec 1836 which is isolated to the optical switch. Also high 'pressure alarm' was in the record. Preventative measures to replace the dso sensor. The dhr revealed no discrepancies. Unknown cause of event.
Patient Sequence No: 1, Text Type: N, H10


[183473745] Information received from abbvie 1562564 duodopa pump was involved with a event were a consumer of the pump was experiencing dyskinesia and bradykinesia which are listed side effect of medication being infused in the duodopa pump. Is was updated that their was no quality problem with the pump, but the physician suspected that there was an issue, so the pump was replaced do to concern,. Do to not knowing if the pump was overdosing or underdosing , this file will be reportable. As over dosing can cause cardiac events, along with hypotension and underdose can cause exacerbation of parkinsons disease. This in turn can cause patient have loss of motor skills, which would cause increase risk for fall and injury. No information on how the pump was programed. The pump is not a cure for the disease but an aide to lessen the uncontrolled motor response the disease manifest.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3012307300-2020-01834
MDR Report Key9832620
Report SourceCONSUMER,DISTRIBUTOR,OTHER
Date Received2020-03-14
Date of Report2020-03-13
Date Mfgr Received2020-02-14
Device Manufacturer Date2018-01-08
Date Added to Maude2020-03-14
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 NameDUODOPA PUMP
Generic NamePUMP, INFUSION, ENTERAL
Product CodeLZH
Date Received2020-03-14
Returned To Mfg2020-03-09
Model Number1400
Catalog Number21-1400-175
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSMITHS MEDICAL ASD,INC
Manufacturer Address6000 NATHAN LANE MINNEAPOLIS, MN US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-14

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