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

Model Number	75483.01
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Blood Loss (2597)
Date of Event	12/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).There was no sample returned or photograph provided.However, the customer confirmed that this connection was a customer made connection of 1/4" tubing connected to the cardioplegia port of a terumo fx25rwc oxygenator.But did not know how far the line had been pushed over the port.The customer did acknowledge the connection had not been 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".Device history record and certificate of conformance was reviewed, no anomalies were found.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 the customer connection of the recirculation line to the oxygenator, cardioplegia port disconnected, approximately 40 minutes into the surgery.This resulted in 150-200 ml blood loss.The line was reconnected and the surgery was successfully completed.The customer indicated the patient was fine.

• 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: 8218241
• Report Number: 1212122-2019-00001
• Device Sequence Number: 1670154
• Product Code: OEZ
• UDI-Device Identifier: 00699753509054
• UDI-Public: (01)00699753509054
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 01/04/2019

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: 08/31/2020
• Device Model Number: 75483.01
• Device Lot Number: WL04
• 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: 12/12/2018
• Initial Report FDA Received Date: 01/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1