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 Hemorrhage/Bleeding (1888)

Event Date 08/04/2023

Event Type  Injury  

Event Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, the oxygenator did not oxygenate blood; there was no gas exchange.As per the user facility, the patient had a redo of mitral and aortic valve replacement, and craniotomy x 2 several days before.The patient had multiple organ failure, and very acidotic from the beginning; they fought acidosis the whole case.The blood flow for the whole case was 5 - 6.5 lpm.Sweep gas started at 7 and gradually increased to 11 within an hour of cpb, it stayed at 11 and treated acidosis with nahco3 the whole case.There was a femoral cannulation.They were on pump prior to opening the chest.First abg after intubation: ph: 6.99, pco2: 37, po2: 253, be: -21, hco3: 9.First abg on pump: ph: 7.16, pco2: 36, po2: 355, be: -15, hc03: 13.Cdi tracking for first hour, abgs were comparable to first abgs.After approximately 1 hour on pump, po2 trended downward; it went from po2 of 202 to po2 of 108 in 10 minutes at 100%.The recirculatory line was opened with little response.The anesthetist was asked to inflate lungs and breathe; with little improvement of po2 from 93 to 106.The anesthetist and surgeon were notified several times about acidosis and concerned about oxygenator maintaining proper oxygenation.An oxygen tank (100%) was switched with no changes in patients po2.Still warm and heart was not arrested.They had been dealing with adhesions, and exposure.It was recommended to come off pump, and changing oxygenator.The supplies were gathered, and they came off pump.Patient was stable with blood pressure in the 130s.The oxygenator was changed out.Reinitiated bypass within 6 minutes, and patient suffered no consequences.Initial abg after back on pump with new oxygenator: 7.26, 36, 325, -10, 16, 99, able to decrease fio2 from 100% to 70%, and maintained po2.Patient's size: 193 cm.There was 225cc of blood loss during the swap out of the oxygenator.The product was changed out.Procedure was completed successfully.

Manufacturer Narrative

Terumo has received the device for evaluation; however, 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: 4614 - serious injury/impairment.Heatlh effect - clinical code: 1888 - hemorrhage/bleeding.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 31, 2023.Upon further investigation of the reported event, the following information is new and/or changed: a2 (added age).A3 (added gender).B5 (describe event or problem - added new information).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 findings: 213 - no device problem found.Investigation conclusions: 67 - no problem detected.The returned sample was inspected upon receipt to show no visual anomalies with the device.After rinsing and drying the sample, it was then tested for its oxygen transfer performance and carbon dioxide removal performance in accordance with product inspection protocol.It met the factory's specifications with no anomaly found in the manufacturing records.As the event could not be replicated, 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.

Event Description

Additional information from the clinical specialist states that, the patient was presented to the or on an intra-aortic balloon pump, and in a severe state of metabolic acidosis and in multiple organ failure.At approximately one hour into the bypass run, the oxygenation decreased suddenly over 10 minutes from a po2 value of 202mmhg to 108mmhg to 93mmhg, at an fio2 of 100%.A separate oxygen tank was used as an alternative source to troubleshoot the oxygenation issue, with no improvement.The decision was made by the clinician to changeout the oxygenator bundle and leave the reservoir in place.The anti-coagulation status of the patient revealed no outstanding issues.The patient was heparinized with 30,000 iu of heparin pre-bypass, resulting in an act of over 600 seconds.The lowest act for the case was 479 seconds.A hemochron jr device was used for act values.A hepcon device, which measures heparin blood concentrations, was not employed.An additional 10,000 iu of heparin was administered to this patient for the bypass run.The act value at the time of decreasing po2 values was 557 seconds, well above acceptable levels.The patient is 193 cm tall.

• 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: 17664564
• MDR Text Key: 322434155
• Report Number: 1124841-2023-00209
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2023
• 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: 3A09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2023
• 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): Other
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 103 KG