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

Model Number	76415
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	08/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Sample was not returned.The issue reported was not confirmed since no sample or sample pictures were received.Therefore, no definite root cause could be determined.Device history record (dhr) was reviewed and no issues were noted related to this complaint.The certificate of conformance (coc) was reviewed for this component and the component was deemed conforming by the supplier.The customer confirmed that this connection was a customer made connection of a 3/8" terumo tubing connected to the outlet of a terumo fx25 oxygenator.The connection was pushed past second barb and not tie-banded.Per the manufacturer's instruction for use (ifu), "pushing user made connections past the second barb and tie-banding all user made connections will prevent disconnection and leaks" and again it stated that "inspect all connections for leaks of any kind, fluid or gas, from inside the circuit to outside, or vice versa.Tie-band and tighten all connections in the circuit.Push tubing past the second barb for user made connections." since the customer did not tie band the connection, the incident could have been caused due to customer technique, but can not be confirmed since there was no sample to evaluate.All available information has been placed on file in quality management for appropriate tracking, trending and follow-up.(b)(4).
Event or Problem Description
It was reported that during a cardiopulmonary bypass (cpb) procedure, the 3/8 inches tubing attached to the outlet port on the fx25 being used got disconnected.The customer made the connection by placing the tubing over the 2nd barb of the oxygenator outlet port.While on bypass the line disconnected resulting in approximately a 500 ml blood loss.The product was not changed out since the perfusionist was able to safely reconnect the line.There was no transfusion required and the surgery was completed successfully.The customer confirmed that patient was okay.

• 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: 7915756
• Report Number: 1212122-2018-00018
• Device Sequence Number: 857461
• Product Code: OEZ
• UDI-Device Identifier: 00699753507227
• UDI-Public: (01)00699753507227
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/27/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: 76415
• Device Lot Number: WE30
• 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: 09/05/2018
• Initial Report FDA Received Date: 09/27/2018
• 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