SORIN 3T HEATER-COOLER SYSTEM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-29 for SORIN 3T HEATER-COOLER SYSTEM manufactured by Livanova Deutschland Gmbh.

MAUDE Entry Details

Report Number9391796
MDR Report Key9391796
Date Received2019-11-29
Date of Report2019-11-19
Date of Event2018-03-08
Report Date2019-11-19
Date Reported to FDA2019-11-19
Date Reported to Mfgr2019-11-29
Date Added to Maude2019-11-29
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSORIN 3T HEATER-COOLER SYSTEM
Generic NameCONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
Product CodeDWC
Date Received2019-11-29
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerLIVANOVA DEUTSCHLAND GMBH
Manufacturer Address14401 WEST 65TH WAY ARVADA CO 80004 US 80004


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-29

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