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

Catalog Number CX-XRY26803A

Device Problems Leak/Splash (1354); Pressure Problem (3012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/16/2019

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 device was received for evaluation.Visual inspection revealed a fluid transparent red in color gathered inside the housing on the gas-in side.There were not any obvious anomalies, such as a break, in the appearance.The fluid gathered inside the housing was collected and a sweep gas was sent into the gas phase from the gas-in side.A fluid in the state of foam was found to be flowing out of the gas-out side.This fluid was collected and tested with a terumo's protein assay strip.It was found to contain protein.The collected fluids were centrifuged.No deposition occurred.This indicates that the fluids are blood plasma which does not contain the erythrocyte components.The actual device was fixed with glutaraldehyde by letting physiological saline solution containing glutaraldehyde go through the oxygenator module by gravity.The housing component was removed for further inspection of the inside of the oxygenator module with the naked eye.No visible clot formation was found.The filter was removed, and its outer and inner surfaces were inspected with the naked eye.There was no visible clot formed on them.Visual inspection of the oxygenator module after the removal of the filter found that the fibers had been slightly discolored partially.The fiber layer was removed from the winding in increments of 2 mm and each layer was subjected to visual inspection.Slight discoloration was noted partially on the fibers.After the fiber layers and the outer cylinder was removed, the heat exchanger module was subjected to visual and magnifying inspections.No clot was found.The removed filter was inspected under magnification.There was no clot adhering on the surfaces.The fiber layers sampled were inspected under magnification.The fibers were found to have been discolored partially.It was found that the closer the layer came to the heat exchanger, the larger the discolored area came to be.There was no clot formation.The filter removed from the oxygenator module was inspected under electron microscope.The erythrocyte components were found to be adhering on it.Electron microscopic inspection of the discolored section of the fiber on each layer revealed the adhesion and aggregation of the erythrocyte components, including blood platelets and white blood cells.The adhesion of blood plasma was found on some fibers.The inner surface of the discolored fiber on each fiber layer was inspected under electron microscope.The presence of escaped blood plasma was found.The cut cross-section of the discolored fiber was inspected under electron microscope.The presence of escaped blood plasma was found.Visual inspection of the reservoir revealed no visible anomaly such as a break on it.Clots were found to have formed inside the cr filter, venous filter and on the inner surface of the head shell.The reservoir was disassembled into each component.Visual inspection of the cr filter and the defoamer taken out of the cr filter found clots adhering on them.Visual inspection of the venous filter and the defoamer taken out of the venous filter found clots adhering on them.Electron microscopic inspection of the cr filter and the defoamer, after having been fixed with glutaraldehyde solution, revealed the formation of fibrin net and the adhesion of the erythrocyte components, including red blood cells.Electron microscopic inspection of the venous filter and the defoamer, after having been fixed with glutaraldehyde solution, revealed the formation of fibrin net and the adhesion of the erythrocyte components, including red blood cells, echinocytes and while blood cells.A review of the device history record of the reported product code/lot number combination was conducted with no findings.A review of the perfusion record was reviewed, and did not find any possible factors which could have been a trigger of the plasma leak in the oxygenator module or of the formation of clots inside the reservoir.Ifu states: do not use this product for a period in excess of six hours.Excessive use for over six hours may lead to plasma leak and thrombi formation, which may compromise the gas exchange performance.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.Based on the investigation results it is likely that a change in the blood properties due to some factor(s), a surface-active substance may be generated in blood.This may have led the balance of the surface tension between the gas and blood which is kept at the micro pores on the surface of the fibers to be upset, resulting in the reported event.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 involved capiox custom pack was used during an emergency case.During circulation, coagulation-related trouble occurred.Despite continued dose of heparin, act became shorter and antithrombin iii was administered.Immediately after the initiation of the circulation, clotting occurred inside the arterial cannula; however, it was not changed out.Around 60 - 90 minutes after the initiation of the circulation, the actual sample (fx15: oxygenator module) started to become degraded in its o2 addition performance.With no rise in the pressure, another oxygenator was added at 19:39 without change-out of the actual sample.At 24:02, a plasma leak was noted in the actual sample (oxygenator module) with clotting in the reservoir.At 24:54 the patient was weaned the bypass.There was no blood loss, and the patient was not harmed.The procedure outcome was not reported.

• 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; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 8869557
• MDR Text Key: 160048729
• Report Number: 9681834-2019-00139
• 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: 08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: CX-XRY26803A
• Device Lot Number: 190411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2019
• 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