MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION NS FX25REC W/RES; BLOOD GAS OXYGENATOR

Model Number 3ZZ*FX25RECA

Device Problem Use of Device Problem (1670)

Patient Problem Abnormal Blood Gases (1034)

Event Date 07/23/2023

Event Type  Death  

Event Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, the oxygenator had a critical decrease in gas exchange.As per the user facility, there was a delay in the procedure, as a new fx 25 oxygenator was cut into the circuit and run in series with the failed oxygenator.This procedure takes time to perform.The case was complicated and the patient was quite ill.The patient required ecmo post surgery, and at approximately 11 hours later, the patient was palliated and deceased immediately upon withdrawal of care.Additionally, the case started at 23:30, for a mitral valve replacement.The duration was 3 hours, form the start of cardiopulmonary bypass, to the changed out needed.They used a centrifugal pump, with the suckers on, cell saver, and hemoconcentrator used, and the surgical field was flooded with carbon dioxide.The patient had heparin, and the act was at 550 - 600, the patient was afebrile at the time of the surgery, with the temperature of 32 degrees celsius.*the product was changed out.*the procedure was completed successfully.

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.H6: component code: 4739 - gas exchanger; health effect - impact code: 1802 - death; health effect - clinical code: 1034 - abnormal blood gases; medical device problem code: 1670 - use of device problem; investigation findings: 3233 - results pending completion of investigation.Investigation conclusions: 11 - conclusion not yet available.

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 august 14, 2023.Upon further investigation of the reported event, the following information is new and/or changed: b5 (describe event or problem - added new information).G3 (date received by manufacturer).G6 (indication that this is a follow-up report).H2 (follow-up due to additional information).A second follow-up will be submitted upon completion of the investigation and/or submission of new information, thus tcvs references conclusions code 11).All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

Event Description

New information received that the patient experienced an unplanned circulatory arrest time of 2 minutes, in which the oxygenator was changed out.The status of the patient with regard to infectious diseases is unknown.He was not tested for any.

Event Description

Oxygenator had a critical decrease in gas exchange.

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations.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 3113, 4114, 3221, 4315).Type of investigation #1: 3331 - analysis of production records.Type of investigation #2: 4114 - device not returned.Investigation findings: 3221 - no findings available.Investigation conclusions: 4315 - cause not established.The actual sample was not returned for evaluation.Without the returned sample and details information of the event, the cause of the occurrence could not be clarified.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: NS FX25REC W/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: 17545406
• MDR Text Key: 321113198
• Report Number: 1124841-2023-00202
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3ZZ*FX25RECA
• Device Catalogue Number: N/A
• Device Lot Number: 3D13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2023
• 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
• Patient Outcome(s): Death
• Patient Weight: 109 KG