CDI BLOOD PARAMETER MONITORING SYSTEM 500 500AHCT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-08-01 for CDI BLOOD PARAMETER MONITORING SYSTEM 500 500AHCT manufactured by Terumo Cardiovascular Systems Corporation.

MAUDE Entry Details

Report Number1828100-2019-00411
MDR Report Key8852386
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-08-01
Date of Report2019-09-03
Date of Event2019-07-02
Date Mfgr Received2019-08-12
Date Added to Maude2019-08-01
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
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 NameCDI BLOOD PARAMETER MONITORING SYSTEM 500
Generic NameMONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS-CDI BPM SYSTEM 500
Product CodeDRY
Date Received2019-08-01
Model Number500AHCT
Catalog Number500AHCT
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
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 2019-08-01

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