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

Model Number	76320
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Codes	Blood Loss (2597); No Known Impact Or Consequence To Patient (2692)
Date of Event	09/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample was not returned.The device history record (dhr) was reviewed and no issues were noted.Incoming inspection results for the tubing and reservoir all passed.There was no trend identified for either the convenience kit, associated tubing or reservoir.No sample or photos were received regarding this issue.The customer confirmed it was a user made connection.The connection was not pushed past the second barb or tie banded.Per the manufacturer's instructions for use (ifu), "all user made tubing connections should be pushed past innermost barb and secured with tie-band." since the customer did not tie band the connection, the incident could have been caused due to customer technique, but this can not be confirmed since there was no sample to evaluate.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 while on cardiopulmonary bypass (cpb), a customer made connection of line 18 to the r1 port on the reservoir, disconnected.It resulted in approximately 100 milliliters (ml) of blood loss and a 1 minute 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: 9178887
• Report Number: 1212122-2019-00010
• Device Sequence Number: 19743476
• Product Code: OEZ
• UDI-Device Identifier: 00699753508460
• UDI-Public: (01)00699753508460
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 10/11/2019

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: 76320
• Device Lot Number: X24898735
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2019
• Initial Report FDA Received Date: 10/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1