MEDFUSION PUMP 3500 3500-500

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 3500-500 manufactured by Smiths Medical Asd, Inc..

Event Text Entries

[185904423] One medfusion pump was received in good physical condition with no appearance of any physical damage. The event history log was reviewed and there was evidence of a primary audible alarm background test. The power up process was conducted and the reported issue was unable to be replicated. No physical or any other damage was found on the speaker or interconnect board. The speaker was replaced as a preventative measure. The force sensor, interconnect board and battery were also replaced.
Patient Sequence No: 1, Text Type: N, H10


[185904424] Information was received indicating that a smiths medical medfusion pump had a primary alarm failure. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3012307300-2020-02629
MDR Report Key9908369
Report SourceCONSUMER
Date Received2020-03-31
Date of Report2020-03-31
Date Mfgr Received2020-03-06
Device Manufacturer Date2011-05-24
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 Mfg2020-03-13
Model Number3500
Catalog Number3500-500
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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