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

Model Number	76810
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Blood Loss (2597); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation anticipated, but not yet begun (02).No sample photo were received for this issue.Device history record (dhr) was reviewed and no issues were noted related to this complaint.The certificate of conformance (coc) was reviewed and the component was deemed conforming by the supplier.It was noted by the customer that the flow through the filter at the time of the incident was over 500 milliliters per minute.This flow is 30% greater than recommended 350 ml/min as stated in the instructions for use.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 use of the device for a cardiopulmonary bypass (cpb) procedure, the leukocyte filter burst while the pulmonoplegia within 2 minutes of initiation.The device was replaced with a straight connector.The surgical procedure was completed successfully.There was no delay, and approximately 200 ml blood loss.No adverse consequences to the patient.

• 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: 8176420
• Report Number: 1212122-2018-00021
• Device Sequence Number: 1326912
• Product Code: OEZ
• UDI-Device Identifier: 00699753509054
• UDI-Public: (01)00699753509054
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 12/18/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: 76810
• Device Lot Number: WM01
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2018
• Initial Report FDA Received Date: 12/18/2018
• 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