MEDFUSION SYRINGE PUMP 3500

MAUDE Adverse Event Report

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

Event Text Entries

[185922026] Returned device was received in good physical condition. Evidence of reported problem in event log was found. During the evaluation of the device, the force sensor test error was found at power up and analysts were unable to calibrate the force sensor. There was contamination found inside of the plunger assembly. This was found to be the cause of the issue. 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


[185922027] Information was received indicating that a smiths medical medfusion syringe pump had an issue with a force sensor. The patient was no impacted by the event. No adverse events were reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3012307300-2020-02614
MDR Report Key9908439
Report SourceUSER FACILITY
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-01-29
Date Mfgr Received2020-03-04
Device Manufacturer Date2009-02-18
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 NameMEDFUSION SYRINGE PUMP
Generic NamePUMP, INFUSION
Product CodeFRN
Date Received2020-03-31
Returned To Mfg2020-03-18
Model Number3500
Catalog Number3500
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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