SARNS CENTRIFUGAL SYSTEM 6379

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-31 for SARNS CENTRIFUGAL SYSTEM 6379 manufactured by Terumo Cardiovascular Systems Corporation.

MAUDE Entry Details

Report Number1828100-2020-00145
MDR Report Key9908689
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2020-03-31
Date of Report2020-04-01
Date of Event2020-03-11
Date Mfgr Received2020-03-11
Device Manufacturer Date2009-11-19
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
Reporter OccupationBIOMEDICAL ENGINEER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. DOUGLAS PATTON
Manufacturer Street6200 JACKSON ROAD
Manufacturer CityANN ARBOR MI 48103
Manufacturer CountryUS
Manufacturer Postal48103
Manufacturer Phone7346634145
Manufacturer G1SAME
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSARNS CENTRIFUGAL SYSTEM
Generic NameCONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS - SARNS CENTRIFUGAL SYSTEM
Product CodeDWA
Date Received2020-03-31
Model Number6379
Catalog Number6379
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerTERUMO CARDIOVASCULAR SYSTEMS CORPORATION
Manufacturer Address6200 JACKSON ROAD ANN ARBOR MI 48103 US 48103


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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