TERUMO CARDIOVASCULAR PROCEDURE KIT 60045

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-05-15 for TERUMO CARDIOVASCULAR PROCEDURE KIT 60045 manufactured by Terumo Cardiovascular Systems Corporation.

Event Text Entries

[145236376] Device evaluation anticipated, but not yet begun. The sample photograph was received confirming the reported issue. It is anticipated that the actual sample will be returned for decontamination and further testing. The device history record (dhr) was reviewed and there were no issues noted. Additionally the ops valve coc indicated the component was deemed conforming by the supplier. All available information has been placed on file in the quality management for appropriate tracking, trending, and follow-up. The case label gtin: (b)(4), the production identifier are (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[145236397] The customer reported a leak in the over pressure safety (ops) valve. The customer had cut this ops valve into a suction line in order to convert it to vent line for aortic valve surgery. The valve leaked during the cardiopulmonary bypass surgery resulting in approximately 5 ml blood loss. The valve was changed out and there was no delay. Surgery was successfully completed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1212122-2019-00006
MDR Report Key8613101
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-05-15
Date of Report2019-07-18
Date of Event2019-04-22
Date Mfgr Received2019-07-16
Device Manufacturer Date2018-01-16
Date Added to Maude2019-05-15
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 ContactMS. KIM MEJIA
Manufacturer Street28 HOWE STREET
Manufacturer CityASHLAND MA 01721
Manufacturer CountryUS
Manufacturer Postal01721
Manufacturer Phone5082312454
Manufacturer G1SAME
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTERUMO CARDIOVASCULAR PROCEDURE KIT
Generic NameCARDIOVASCULAR PROCEDURE KIT- CONVENIENCE TUBING PACK
Product CodeOEZ
Date Received2019-05-15
Model Number60045
Catalog Number60045
Lot NumberWA15
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerTERUMO CARDIOVASCULAR SYSTEMS CORPORATION
Manufacturer Address28 HOWE STREET ASHLAND MA 01721 US 01721


Patients

Patient NumberTreatmentOutcomeDate
10 2019-05-15

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