CAPIOX FX25 OXYGENATOR ZZ*FX25RW

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 2020-03-03 for CAPIOX FX25 OXYGENATOR ZZ*FX25RW manufactured by Terumo Corporation, Ashitaka.

MAUDE Entry Details

Report Number9681834-2020-00026
MDR Report Key9779216
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-03
Date of Report2020-03-03
Date of Event2020-01-29
Date Mfgr Received2020-02-04
Device Manufacturer Date2019-03-26
Date Added to Maude2020-03-03
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 ContactTHERESA MUSSAW
Manufacturer StreetREG. NO. 2243441 950 ELKTON BLVD.
Manufacturer CityELKTON, MD
Manufacturer CountryUS
Manufacturer Phone2837866718
Manufacturer G1TERUMO CORPORATION, ASHITAKA
Manufacturer StreetREG. NO. 9681834 150 MAIMAIGI-CHO
Manufacturer CityFUJINOMIYA CITY, 418
Manufacturer CountryJA
Manufacturer Postal Code418
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCAPIOX FX25 OXYGENATOR
Generic NameOXYGENATOR, CARDIOPULMONARY BYPASS
Product CodeDTZ
Date Received2020-03-03
Model NumberNA
Catalog NumberZZ*FX25RW
Lot Number190326
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTERUMO CORPORATION, ASHITAKA
Manufacturer Address150 MAIMAIGI-CHO FUJINOMIYA CITY, 418 JA 418


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2020-03-03

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