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

Model Number	76168
Medical Device Problem Codes	Disconnection (1171); Connection Problem (2900)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Blood Loss (2597)
Date of Event	06/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint sample, or photo of the issue was not received.An evaluation of the device history record and the inspection/coc information for the connector and tubing, showed there were no discrepancies noted.It was learned that the user did not tie band the connection as is noted in the instructions for use for the convenience kit.Specifically under precautions section 6 "pushing user made connections past the second barb and tie-banding all user made connections will prevent disconnection and leaks".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 a cardiopulmonary bypass (cpb) procedure, the tubing on line 13 disconnected from the 1/4'' connector port on line 3.This disconnect of a user made connection resulted in a 200 cc blood loss.The line was reconnected and not changed out.There was no delay and the surgery 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: 7645385
• Report Number: 1212122-2018-00009
• Device Sequence Number: 125824
• Product Code: OEZ
• UDI-Device Identifier: 00699753505469
• UDI-Public: (01)00699753505469
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Report Date (Section B): 06/28/2018

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: 76168
• Device Lot Number: WC12
• 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: 06/05/2018
• Initial Report FDA Received Date: 06/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1