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

Model Number	75533
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250); Connection Problem (2900)
Health Effect - Clinical Codes	Blood Loss (2597); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation is in progress, but not yet concluded.(b)(4).A sample was received and decontaminated.Both visual and photographic review indicated that there was crazing on the female large bore luer, and a crack parallel to the parting line.The sample was also tested for leaks and was found to leak at a pressure of 20 mmhg.A representative sample was used to test the impact of solvent exposure to the connector, the test showed that no cracking on crazing occurred when exposed to solvent for 20+ hours.Another representative sample was used to test the impact of over tightening the luer when mated with the male counterpart.No cracking or crazing occurred as a result of this test.The sample will be sent to supplier for further evaluation.The device history record (dhr) was reviewed and there were no issues noted.The incoming raw material documentation, including the certificate of conformance and inspection results, were reviewed and there were no issues noted.All available information has been placed on file in quality management for appropriate tracking, trending and follow-up.(b)(4).
Event or Problem Description
The customer reported that during cardiopulmonary bypass (cpb) procedure, the large luer on end of line (17b, l2) was a cracked and leaking.It resulted in approximately 5 cc blood loss.The device was changed out.The surgical procedure was completed successfully but there was a 5 minutes delay occurred.
Additional Manufacturer Narrative
The supplier inspected the part returned and confirmed the crack in the threaded part of the component as well as stress marks along the thread.They attempted to replicate the defect by overtightening the mated component and trying to crush the component with no success.They said that the root cause of the damage of the threaded section of the component is unknown at this time.The damage in the component is most likely caused by an incidental and isolated mold closure on the component during the molding process.There was no containment actions taken since they determined the issue to be an isolated incident (incident rate (b)(4)) and the lot has been depleted in total from their inventory.They did inspect current inventory and no issues were found.All available information has been placed on file in the quality management system 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: 7624700
• Report Number: 1212122-2018-00008
• Device Sequence Number: 18883253
• Product Code: OEZ
• UDI-Device Identifier: 00699753498990
• UDI-Public: (01)00699753498990
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2018

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: 09/30/2019
• Device Model Number: 75533
• Device Lot Number: VM23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/29/2018
• Supplement Date Received by Manufacturer: 07/03/2018
• Initial Report FDA Received Date: 06/21/2018
• Supplement Report FDA Received Date: 07/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1