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

Model Number	75106-02
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Blood Loss (2597)
Date of Event	01/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sample was not returned.The sample itself was not received however a photograph of the line was received.The customer confirmed that the 3/8" x 3/8" connector located on line 5 was a user made connection to another manufacturer's tubing.The customer also acknowledge that the connection was not tie-banded.Per manufacturer's instructions for use (ifu), "the connection may result in a leak if the instructions for user made connections are not followed.All user made connections to pvc tubing must be, at a minimum, pushed past the first barb and tie banded." the device history record (dhr) was reviewed and there were no issues noted.Additional the connector inspection records passed incoming inspection and the 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.(b)(4).
Event or Problem Description
It was reported that during the cardiopulmonary bypass (cpb) procedure, the tubing connector from the terumo cardiovascular procedure kit and the tubing from another manufacturer's kit disconnected, resulting in approximately 2000-2200 ml blood loss.This was a user made connection that had not been tie banded.There was a delay of approximately 3 minutes while the connector and tubing were reconnected.The user indicated there was no blood transfusion required.The surgery was successfully completed.It was also reported that there no serious adverse patient impact or post-surgical complications.

• 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: 8278861
• Report Number: 1212122-2019-00004
• Device Sequence Number: 1516455
• Product Code: OEZ
• UDI-Device Identifier: 00699753504677
• UDI-Public: (01)00699753504677
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: 75106-02
• Device Lot Number: WM08
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2019
• Initial Report FDA Received Date: 01/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention