CSC14 BLOOD CARDIOPLEGIA SYSTEM 025310

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-07-05 for CSC14 BLOOD CARDIOPLEGIA SYSTEM 025310 manufactured by Sorin Group Italia Srl.

MAUDE Entry Details

Report Number9680841-2019-00027
MDR Report Key8763688
Report SourceHEALTH PROFESSIONAL
Date Received2019-07-05
Date of Report2019-08-09
Date of Event2019-06-04
Date Mfgr Received2019-07-12
Device Manufacturer Date2019-05-14
Date Added to Maude2019-07-05
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 ContactALESSANDRO MELCHIORRE
Manufacturer Street14401 W 65TH WAY
Manufacturer CityARVADA CO 80004
Manufacturer CountryUS
Manufacturer Postal80004
Manufacturer G1SORIN GROUP ITALIA SRL
Manufacturer StreetSTRADA STATALE 12 NORD, 86
Manufacturer CityMIRANDOLA, MODENA 41037
Manufacturer CountryIT
Manufacturer Postal Code41037
Single Use3
Remedial ActionOT
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCSC14 BLOOD CARDIOPLEGIA SYSTEM
Generic NameHEAT-EXCHANGER, CARDIOPULMONARY BYPASS
Product CodeDTR
Date Received2019-07-05
Returned To Mfg2019-06-20
Catalog Number025310
Lot Number1903280056
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSORIN GROUP ITALIA SRL
Manufacturer AddressSTRADA STATALE 12 NORD, 86 MIRANDOLA, MODENA US


Patients

Patient NumberTreatmentOutcomeDate
10 2019-07-05

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