MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX25 OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number CX*FX25RW

Device Problems Decrease in Pressure (1490); Increase in Pressure (1491)

Patient Problem No Information (3190)

Event Date 02/13/2020

Event Type  Injury  

Manufacturer Narrative

Patient identifier - (b)(6).Implanted date: device was not implanted.Explanted date: device was not explanted.Pma/510(k)- k130520.The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.A review of the device history record and product release decision control sheet of the involved product code/lot# combination was conducted with no findings.(b)(4).

Event Description

The user facility reported that the involved capiox device was used during the procedure.They started the surgical procedure; interarticular communication without apparent incidents.They proceeded to administer heparin, and performed aortic cannulation without incident, without pressure gradients between mean blood pressure and aortic pressure.Both cavas, left cavities and aortic root without mishaps are cannulated.Dcp was started without apparent incidents, the aorta was clamped and cardioplegia administration of the nest began, just at that moment when the cardioplegia was being administered the centrifugal machine stopped.The mean arterial pressure dropped, and the presence of air is detected in the venous line on its way.At that time, it was decided to perform circulatory arrest with cerebral protection at 32 degrees which was the current temperature of the patient (ice is placed on the patient's head, medications are administered for brain protection).It was decided to change the centrifuge, thinking that it was the machine that failed first intention.However, no favorable results were obtained.They changed from centrifuge to rollers, without favorable results.The oxygenator was changed, it was primed with the volume recovered from the first oxygenator, the circuit is recirculated and the dcp is restarted, recovering cardiac output and continuing with the perfusion protocol established for the patient.It is observed that even with the change of oxygenator there was pressure greater than 360 in the measurement line of the aortic pressure, so it was excluded to avoid damage and dissection of the same; immediately the doctor is notified.The procedure was completed successfully.At the end of the dcp, functionality of both centrifugal machines was checked without any problem.Therefore, the malfunction of them was ruled out.The final patient impact was not reported.

Event Description

Additional information was received 16mar2020.It was reported that the patient had passed away.The pressure in the aortic pressure line was high even after product replacement during use and did not improve.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide additional information in section b5 and the completed investigation results.It was initially reported that the actual device was available; however, the device was not returned.Therefore, sections d10 ad h3 have been updated.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.The lot of the fiber used for this product code/lot was confirmed to be 190728-2 and 190728-3.The performance test results of the above-mentioned fiber lots were reviewed and revealed no anomaly.Ifu states: adequate heparinization of the blood is required to prevent it from clotting in the system.Do not reduce heparin during circulation.Otherwise, blood clotting might occur.Based on the complaint description that high pressure in the aortic line was still observed after the actual sample was exchanged, it is likely that a blood clot may have formed due to some factors, which resulted in obstructing the circuit.However, with no return of the actual device, the exact cause of the reported event cannot be definitively determined based on the available information.

Manufacturer Narrative

This report is being submitted as follow up no.2 to provide the device return date in section d10, update section h3, and to provide the completed investigation results.Visual inspection of the actual sample revealed no obvious anomalies, such as a break, in the appearance.The actual sample was rinsed, dried and then built into a circuit.Bovine blood (@hct35% and temp.37°c) was circulated in the circuit, while the pressure drop was determined at each flow rate.The obtained values were confirmed to meet the manufacturer specifications.No obstruction was confirmed.The actual sample was flushed with water.No clot that could lead to an increase in the pressure was found inside the actual sample.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.The investigation results verified the returned sample was of the normal product.Based on the complaint description, that high pressure in the aortic line was still observed after the actual sample was exchanged, it is likely that a blood clot may have formed due to some factors, which resulted in obstructing the circuit.However, the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: CAPIOX FX25 OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 9797376
• MDR Text Key: 196403498
• Report Number: 9681834-2020-00032
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350701046
• UDI-Public: 04987350701046
• Combination Product (y/n): N
• PMA/PMN Number: K071494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: CX*FX25RW
• Device Lot Number: 190924K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2020
• Date Manufacturer Received: 04/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEPARIN
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 43 YR
• Patient Weight: 67