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

Model Number	76735
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Codes	Blood Loss (2597); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample was received and decontaminated.Photos were reviewed of the pre-decontaminated samples and there was evidence of blood at the interface between the two connectors.When the sample was evaluated it connect properly and there was no evidence of damage to the gasket.Next the sample was pressurized to 1500mmhg for approximately 1 minute and there was no evidence of a leak.The sample was not changed out during the surgery indicating the user made connection was most likely reconnected prior to initiating bypass.The device history record (dhr) was reviewed and no issues were noted.All available information has been placed on file in the quality management for appropriate tracking, trending, and follow-up.(b)(4).
Event or Problem Description
The customer reported that during pre-cardiopulmonary bypass (cpb) procedure, the customer made connection of the quick connector became disconnected during circulation.It resulted in less than 10 milliliter (ml) of blood loss.There was a 10 minutes delay to the procedure.The product was not changed out and the surgical procedure was completed successfully.

• 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: 9072037
• Report Number: 1212122-2019-00008
• Device Sequence Number: 3070291
• Product Code: OEZ
• UDI-Device Identifier: 00699753508668
• UDI-Public: (01)00699753508668
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2019

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: 04/30/2021
• Device Model Number: 76735
• Device Lot Number: X28901264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2019
• Initial Report FDA Received Date: 09/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1