MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX25RWC W/ RES; BLOOD GAS OXYGENATOR

Model Number 3CX*FX25RWC

Device Problem Use of Device Problem (1670)

Patient Problem Cardiac Arrest (1762)

Event Date 01/31/2023

Event Type  Death  

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: 4739 - gas exchanger.Health effect - impact code: 1802 - death.Health effect - clinical code: 1762 - cardiac arrest.Medical device problem code: 1670 - use of device problem.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 an oxygen failure in the procedure with p02 levels under 50mmhg with fi02 at 100%.The patient died.There was 2 or 3 minutes delay without extracorporeal circulation.There was 260 ml as static volume in the oxygenator that was changed and additional volume in lines.The product was changed out.The surgery 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 february 23, 2023.Upon further investigation of the reported event, the following information is new and/or changed: d9 (device availability - added date returned to manufacturer).G3 (date received by manufacturer).G6 (indication that this is a follow-up report).H2 (follow-up due to additional information).H3 (device evaluation anticipated by manufacturer - 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 from the clinical specialist indicates that the patient was a 63-year-old male with a weight of 66kg and a bsa of 1.7m2.The patient was very sick and the surgical procedure was an aortic and mitral valve replacement and tricuspid valve repair.The pump run was 268+98=366 minutes long.The surgery was a high-risk procedure considering the complexity of the disease, heart failure and long length of bypass time.The patient died 15 days post-surgery.A 2 - 3 minute delay in blood circulation during the changeout of the oxygenator would not be the primary cause of death in this patient.The time it took to change the oxygenator out is a reasonable amount for that clinical procedure.A pump record was provided by the customer for the case.Heparin management for the case seem to be reasonable, with act values above expected minimums.No hepcon device, that measures heparin blood concentrations was used.Reviewing the blood gases available from the pump record, a strange pattern becomes evident.An acceptable po2 value is followed by a very low po2 value and then followed by another acceptable po2 value.This pattern seems to be repeated at least 3 times in the pump record.The fio2 was consistently at 90 % during these following periods and not changed.At 10:46, the po2 was 247mmhg, at 10:54 the po2 was 50mmhg (low), and then at 11;10 it was back up to 187mmhg.This pattern occurred again at 12:03, the po2 was 154mmhg, at 12:06 the po2 was 46mmhg (low) and then at 12:33 it was back up to 102mmhg.It is not clear from the pump record when the oxygenator changeout occurred.This pattern would seem to indicate more of a gas supply issue, whether from the hospital main gas source or from the heart lung machine, than an oxygenator bundle issue.

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: a2 (patient information - corrected age).A4 (added patient's weight).B5 (describe event or problem).G3 (date received by manufacturer).G6 (indication that this is a follow-up report).H2 (follow-up due to correction and additional information).H3 (device evaluation anticipated by manufacturer - a third 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.

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 expiration date).G3 (date received by manufacturer).G6 (indication that this is a follow-up report).H2 (follow-up due to additional information and device evaluation).H3 (device evaluated by manufacturer).H4 (device manufacture date).H6 (identification of evaluation codes 10, 3331, 213, 67).Type of investigation #1: 10 - testing of actual/suspected device.Type of investigation #2: 3331 - analysis of production records.Investigation finding: 213 - no device problem found.Investigation conclusions: 67 - no problem detected.The actual sample was visually inspected was found to have no anomaly such as breakage.After rinsed and dried, the sample was tested for the oxygen transfer and carbon dioxide removal in accordance with the product inspection protocol.The test result met the factory's control standards, and no anomaly was found.Review of the manufacturing record and incoming inspection record of the actual sample found no anomaly in them.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

Event Description

Oxygen failure in the procedure with po2 levels under 50 mmhg with fio2 at 100%.

• Brand Name: STERILE FX25RWC 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: jamie quinlan ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 16428106
• MDR Text Key: 310071764
• Report Number: 1124841-2023-00057
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450837
• UDI-Public: (01)00699753450837
• Combination Product (y/n): N
• Reporter Country Code: EC
• 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,Followup,Followup
• Report Date: 05/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3CX*FX25RWC
• Device Catalogue Number: N/A
• Device Lot Number: ZN15R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2021
• 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 Age: 63 YR
• Patient Sex: Male
• Patient Weight: 66 KG