CENTRIMAG VAD KIT (OUS)- VAS/ECMO 201-90001

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 2019-07-29 for CENTRIMAG VAD KIT (OUS)- VAS/ECMO 201-90001 manufactured by Thoratec Corporation.

Event Text Entries

[152518913] Approximate age of device: the event occurred on the date of implant. No further information was provided. The patient remains ongoing on the device. A supplemental report will be submitted when the manufacturer's investigation is completed.
Patient Sequence No: 1, Text Type: N, H10


[152518914] The surgical team reportedly opened an expired centrimag implant kit and used the blood pump, cannulas, and tubing that were not expired according to each product's individual expiration date. Cannula connectors that had individual expiration dates that had already passed were discarded and replaced. The manufacturer's representative advised the surgical team to discard the entire kit. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2916596-2019-03674
MDR Report Key8837194
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-07-29
Date of Report2019-07-29
Date of Event2019-07-05
Date Mfgr Received2019-07-05
Date Added to Maude2019-07-29
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 ContactMR. BOB FRYC
Manufacturer Street6035 STONERIDGE DRIVE
Manufacturer CityPLEASANTON CA 94588
Manufacturer CountryUS
Manufacturer Postal94588
Manufacturer Phone7818528204
Manufacturer G1THORATEC CORPORATION
Manufacturer Street6035 STONERIDGE DRIVE
Manufacturer CityPLEASANTON CA 95488
Manufacturer CountryUS
Manufacturer Postal Code95488
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCENTRIMAG VAD KIT (OUS)- VAS/ECMO
Generic NameCENTRIMAG BLOOD PUMP KIT
Product CodeOJE
Date Received2019-07-29
Model Number201-90001
Catalog Number201-90001
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTHORATEC CORPORATION
Manufacturer Address6035 STONERIDGE DRIVE PLEASANTON CA 95488 US 95488


Patients

Patient NumberTreatmentOutcomeDate
10 2019-07-29

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