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

Catalog Number CX-CRX07802A

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/16/2020

Event Type  malfunction  

Manufacturer Narrative

Udi: not required for product code.Implanted date: device was not implanted.Explanted date: device was not explanted.510k - k130520.The actual sample was received for evaluation.Visual inspection did not reveal any anomaly including a breakage in the appearance.Air was blown into the actual sample upon receipt from the gas in port.No liquid flowing out from the gas out port was observed.The count of blood cells in the liquid collected from the blood channel of the actual sample was analyzed and it was found that each item was lower than the standard value.Physiological saline solution was flown into the actual sample by gravity and the oxygenation module was inspected visually.Formation of blood clot adhering to the bottom was observed.Because blood was found on the bottom of the oxygenator at the time of its arrival at the factory, the blood clots may have formed during the return transportation to the factory.The actual sample was built in a circuit consisting of a tube and filled with a physiological saline solution, and then the pressure drop was determined while it was circulated in a flow rate range of 0.5 to 4.0 l / min.The actual sample showed high values compared to those of a current product sample.From the test results, it was not clarified when the formation of blood clot occurred (during circulation or the return transportation).The inside of the oxygenation module was fixed by being filled with glutaraldehyde-containing saline solution.Then, the housing and the filter were removed and subjected to visual inspection.Formation of blood clots was found visibly on the outer surface of the filter.The oxygenation module was visually inspected.The surface of the fiber was found to have become pale pink, however, no visible formation of blood clots was confirmed.The fiber layer was removed gradually by 2mm in thickness and the surface of each layer was subjected to visual inspection.Small blood clots were found to have formed on the surfaces.The heat exchanger was removed from the outer cylinder, and subjected to visual and magnifying inspections.Blood clots were found to have formed in the bottom.The filter that had been removed was inspected under magnification.No anomaly was observed in the diameter of the filter mesh.Blood clots were found to have formed on the outer surface.The removed fiber layers were inspected under magnification.Blood clots were found to have adhered on the surface.The points marked with blue circles showed that the fiber had become transparent.Based on this, it was assumable that the fiber might have turned to be hydrophilic.The cross-section of the fiber was examined with sem for the discolored points of the fiber.As a result, white spot was found in the micropores, indicating the possibility of blood plasma infiltration.Since the cross-section of the fiber may be crushed when cut with a blade, the fiber was frozen with liquid nitrogen and then fractured for this inspection.A review of the device history record and product release decision control sheet of the product code/lot# combination was conducted with no findings.Review of the pump record revealed: at 21:39, circulation started.At 22:29, ao clamp.At 0:43, ao declamp.At 1:19, ecmo was introduced.At 22:33, po2 decreased below 200mmhg and continued decreasing gradually.At 1:19, when ecmo was introduced, po2 increased from 50mmhg level to 400mmhg level.By plotting po2 and rectal temperature, it was found that po2 decreased below 200mmhg at 23:33 just after the rectal temperature reached the lowest temperature at 23:32.Po2 continued decreasing during rewarming.By plotting svo2 and rectal temperature, it was found that svo2 dropped markedly at 23:58 in the course of rewarming.From 23:33, when po2 dropped below 200mmhg, fio2 was kept raised, however, po2 continued decreasing.The following possibilities were inferred: since the po2 decreased immediately after the rectal temperature reached the lowest temperature at 23:32, it was assumable that there was a cause of the decrease in po2 other than the re-warming; since the decrease in svo2 was observed during the rewarming, the metabolism of the patient was increased by the rewarming, and the svo2 decreased due to an increase in oxygen consumption, which may have led to the decrease in po2.Ifu states: a phenomenon called wet lung may occur when water condensation occurs inside fibers of microporous membrane oxygenators with blood flowing exterior to the fibers.This may occur when oxygenators are used for a longer period of time.If water condensation and/or a decrease in pao2 and/or an increase in paco2 is noted during extended oxygenator use, briefly increasing the gas flow rate may improve the performance.Increase gas flow rate, to 20 l/min for 10 seconds.Do not repeat this flushing technique, even if oxygenator performance is not improved.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.It is likely that a change in the blood properties produced a substance with a surface-active effect.Due to this, the fibers became hydrophilic and the contact between gas and blood was inhibited, which resulted in the decrease in oxygenation capacity; decrease in svo2 was observed during rewarming.Based on this, it was assumable that the volume of supplied o2 became insufficient for the o2 consumption volume that increased due to the patient's metabolism activated by the rewarming, which resulted in the decrease in svo2, and the decrease in po2 accordingly.However, the exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).

Event Description

The user facility reported that the capiox custom pack was used during the procedure.Oxygenation performance of pre-connected fx25 became insufficient during emergency case (major vessel).Patient bsa:2.0.Pump flow:5l/min, svo2 greater than or equal to 70, fio2 was set to 100%.Emergency case, patient was in bad condition, blood condition was not good.No problem was found at the beginning.Oxygenation performance became insufficient during rewarming.There was no change of the oxygenator.The procedure was completed successfully.The patient was no harmed.

• Brand Name: CAPIOX FX OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: theresa mussaw ; reg. no. 2243441; 265 davidson ave suite 320; somerset, nj ; 2837866718
• MDR Report Key: 9942479
• MDR Text Key: 213716692
• Report Number: 9681834-2020-00050
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: CX-CRX07802A
• Device Lot Number: 200131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2020
• 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