MEDFUSION PUMP 3500 3500-414

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-31 for MEDFUSION PUMP 3500 3500-414 manufactured by Smiths Medical Asd, Inc..

Event Text Entries

[185905560] One medfusion pump was returned in excellent physical condition. The event history log was reviewed and a primary audible alarm post was found. Power up process and occlusion test were performed. No test could pass due to the initial primary audible alarm post error alarm. A high profile c9 capacitor on the interconnect printed circuit board (pcb) was found broken off which prevented all other tests and functions of the device. The interconnect pcb was replaced and the speaker was replaced for precaution. The power up process was performed as well as functional testing which passed.
Patient Sequence No: 1, Text Type: N, H10


[185905561] Information was received indicating that a smiths medical medfusion pump failed occlusion test. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3012307300-2020-02627
MDR Report Key9908363
Report SourceCONSUMER
Date Received2020-03-31
Date of Report2020-03-31
Date Mfgr Received2020-03-06
Device Manufacturer Date2007-02-23
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 NameMEDFUSION PUMP
Generic NamePUMP, INFUSION
Product CodeFRN
Date Received2020-03-31
Returned To Mfg2020-03-16
Model Number3500
Catalog Number3500-414
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

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.