MEDFUSION SYRINGE PUMP 4000 4000-0105-51

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 4000 4000-0105-51 manufactured by Smiths Medical Asd, Inc..

Event Text Entries

[185922818] Returned device was received in good physical condition. Evidence of reported problem in event log was found. During the evaluation of the device, analysts were unable to duplicate the error. The speaker was replaced as a preventative measure. 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


[185922819] Information was received indicating that a smiths medical medfusion syringe pump presented with an acu watchdog alarm. No adverse events were reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3012307300-2020-02608
MDR Report Key9908437
Report SourceUSER FACILITY
Date Received2020-03-31
Date of Report2020-03-31
Date Mfgr Received2020-03-03
Device Manufacturer Date2016-06-30
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 Mfg2020-03-09
Model Number4000
Catalog Number4000-0105-51
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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