MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION TERUMO CARDIOVASCULAR PROCEDURE KIT; CARDIOVASCULAR PROCEDURE KIT- CONVENIENCE TUBING PACK

Model Number	60045
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Blood Loss (2597); No Known Impact Or Consequence To Patient (2692)
Date of Event	04/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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).
Event or Problem Description
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.
Additional Manufacturer Narrative
This follow-up is submitted to the fda in accord with applicable regulations - and as indicated by terumo cardiovascular systems corporation in the follow-up report submitted july 9, 2019.Upon further investigation of this reported event, the following information is new and/or changed: g4 (date received by manufacturer).G7 (indication that this is a follow-up report).H2 (follow-up due to additional information and device evaluation).H6 (identification of evaluation codes).H6 results: 4210 - leakage/seal.H6 conclusion 4307 - cause traced to component failure.The sample was sent to the supplier for testing.The complaint sample was decontaminated prior to investigation.The sample showed presence of blood under the dome.Based on the complaint condition described the valve was tested for leaking at low pressure.The hood of the device was dis-assembled, and blood was noted under the pressure relief band.This band appeared to have relieved pressure during surgery potentially multiple times; resulting in blood build up under the relief valve.The blood build up potentially created a leak path, resulting in lower pressure relief.The supplier determined the root cause of the reported issue of leaking at a lower pressure was due to the presence of blood under the band.All available information has been placed on file in quality management for appropriate tracking, trending and follow-up.
Additional Manufacturer Narrative
This follow-up is submitted to the fda in accord with applicable regulations - and as indicated by terumo cardiovascular systems corporation in the initial report submitted may 15, 2019.G4 (date received by manufacturer).G7 (indication that this is a follow-up report).H2 (follow-up due to additional information and device evaluation).H3 (indicates device evaluated).H6 (identification of method code).H6 method: 10-actual device evaluated.A sample was received and sample photographs were taken prior to decontamination.Visual inspection did not show any abnormalities.There were no observed cracks, chips, or deformation noted on the valve.The red cap appeared to be assembled correctly on the valve.The sample has been sent to the supplier for further testing.All available information has been placed on file in quality management for appropriate tracking, trending and follow-up.

• Brand Name: TERUMO CARDIOVASCULAR PROCEDURE KIT
• Common Device Name: CARDIOVASCULAR PROCEDURE KIT- CONVENIENCE TUBING PACK
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 28 howe street; ashland MA 01721
• MDR Report Key: 8613101
• Report Number: 1212122-2019-00006
• Device Sequence Number: 11278997
• Product Code: OEZ
• UDI-Device Identifier: 50699753453628
• UDI-Public: (01)50699753453628
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: 60045
• Device Catalogue Number: 60045
• Device Lot Number: WA15
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/22/2019
• Supplement Date Received by Manufacturer: 06/14/2019; 07/16/2019
• Initial Report FDA Received Date: 05/15/2019
• Supplement Report FDA Received Date: 07/09/2019; 07/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1