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

Model Number	B72736-02
Medical Device Problem Codes	Misconnection (1399); Device Operational Issue (2914)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	05/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) was reviewed and there were no issues related to the 3/8¿x1/4¿x3/8¿ y component or the assembly of line #13.The sample was received, decontaminated and assessed.The sample had two tie bands on the ¼ port and a portion of tubing from another manufacturer¿s pack.This was a user made connection.The tie-bands and tubing were removed from the returned sample and through visual inspection it was noted there was no damage or deformation to the ¼¿ port.Next the first and second barb were measured, and the dimensions were found to be within specification.It was also learned during the investigation that the initial connection was not tie-banded.The two tie-bands were added when the line was reconnected.Per terumo cardiovascular procedure kit ifu precautions ¿6) pushing user made connections past the second barb and tie-banding all user made connections will prevent disconnection and leaks.¿ terumo does not manufacturer or distribute the quest microplegia.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), a tubing (from another manufacturer's device) disconnected from 3/8" x 3/8" x 1/4" "y" connector.This was a user made connection.The disconnection resulted in approximately 750cc blood loss.The product was not changed out.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: 7604861
• Report Number: 1212122-2018-00007
• Device Sequence Number: 1590146
• Product Code: OEZ
• UDI-Device Identifier: 00699753497184
• UDI-Public: (01)00699753497184
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 06/15/2018

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: B72736-02
• Device Lot Number: WC12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2018
• Initial Report FDA Received Date: 06/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: QUEST MICROPLEGIA