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	05/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sample was not returned.The device history record (dhr) was reviewed and there were no issues noted.Additionally both the inspection data and coc information was reviewed for the tubing and connector and there were no discrepancies noted.The reported issue was not confirmed as no sample was returned for evaluation.A photograph was provided however there was no evidence of disconnection and therefore the issue could not be confirmed through the photograph.The disconnection occurred on a customer made connection.The customer made the tubing connection from line 6 to the open y connector 3/8'' port on line 7.The customer did report that the tubing connection was tie banded at the time of the disconnection.It is unknown if the connection was made properly per the cardiovascular kit ifu.All available information has been placed on file in quality management for appropriate tracking, trending and follow up.(b)(4).No sample was returned.
Event or Problem Description
The customer reported that during cardiopulmonary bypass (cpb) procedure, the tubing on line 6 disconnected from the open 3/8'' connector port on line 7 (a user-made connection) resulting in 200cc blood loss.There was a 1 to 2 minutes of delay while the line was reconnected.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: 7582047
• Report Number: 1212122-2018-00005
• Device Sequence Number: 2062786
• 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): 06/08/2018

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: WC05
• 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: 05/16/2018
• Initial Report FDA Received Date: 06/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1