MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX15RWC W/ 4L RES; BLOOD GAS OXYGENATOR

Model Number 3CX*FX15RW40C

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/05/2023

Event Type  malfunction  

Manufacturer Narrative

Terumo has not received the device for evaluation; therefore, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is complete and when more information becomes available.For this reason, terumo references evaluation conclusion code 11.Component code: 934- reservoir health effect ¿ impact code: 2199-no health consequences or impact.Health effect ¿ clinical code: 4582- no clinical signs, symptoms or conditions.Medical device problem code: 1096- coagulation in device or device ingredient.Investigation findings: 3233 - results pending completion of investigation.Investigation conclusions: 11 - conclusion not yet available.

Event Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, there was clots on the oxygenator reservoir.As per the subsidiary, they monitored closely and the case ended without any delays, and without changing out.No known consequence or health impact to patient.Product was not changed out.Procedure was completed successfully.

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on june 26, 2023.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added exp date); g3 (date received by manufacturer); g6 (indication that this is a follow-up report); h2 (follow-up due to additional information); h4 (device manufacture date); h6 (identification of evaluation codes 4114, 11, 3331, 3244, 4315).Type of investigation #1: 4114 - device not returned.Type of investigation #2: 11 - testing of device from same lot/batch retained by manufacturer.Type of investigation #3: 3331 - analysis of production records.Investigation findings: 3244 - problem due to thrombosis activation.Investigation conclusions: 4315- caused not established.The sample was not returned for evaluation; however, a photo was provided showing clots on the outside of the vr filter.A representative retention sample from the same lot number was obtained and tested.The sample was tested for clotting with bovine blood at 8 l/minute for 1 hour with no clotting on the filter observed in the venous portion of the reservoir.Without the returned sample, a thorough investigation could not be performed, and a definitive root cause could not be determined.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

Event Description

Oxygenator reservoir have clots.

• Brand Name: STERILE FX15RWC W/ 4L RES
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• Manufacturer (Section G): SAME
• Manufacturer Contact: douglas patton ; 125 blue ball road; elkton, MD 21921 ; 7346634145
• MDR Report Key: 17199333
• MDR Text Key: 318241256
• Report Number: 1124841-2023-00160
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450790
• UDI-Public: (01)00699753450790
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K151791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3CX*FX15RW40C
• Device Catalogue Number: N/A
• Device Lot Number: 2L19
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1