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

Catalog Number CX-XRY53301

Device Problem Gas Output Problem (1266)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/07/2018

Event Type  Injury  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.The 510(k): k130520.The actual device was returned for evaluation.Visual inspection revealed a liquid red in color pooling inside the housing on the gas-in side.There were no other anomalies found.The liquid pooled inside the housing was collected and a sweep gas was sent into the gas phase from the gas-in side.A liquid was found to be flowing out of the gas-out side.The liquid collected was tested, and it contained protein.The liquid collected by sweeping the gas through the gas phase was centrifuged.No deposition occurred.This indicated that the liquid was the blood plasma component.Saline solution was let to flow through the actual device by gravity drop.Subsequent visual inspection of the actual device found that the components inside the housing component had been discolored.The actual device was fixed by letting saline solution containing glutaraldehyde solution to flow through the actual device by gravity drop.The housing component was removed for further inspection of the inside of the oxygenator module.Any clot that was visible with the naked eye was not found on the outer surface of the filter.The filter was removed from the actual device for further inspection of its outer and inner surfaces.There was no discoloration or no clot adhesion on either surfaces.Visual inspection of the uncovered fiber found it had been partially discolored.The state of the fiber winding was confirmed to be normal.The fiber layer was removed from the winding in increments of 2 mm and each layer was subjected to visual inspection.The fiber was found to have been discolored partially.There was no clot formation that was visible with the naked eye on the fiber winding.The filter removed from the main body was inspected under magnification; no clot formation was confirmed.The fiber layers removed were inspected under magnification.They were found to have been discolored partially.It was noted that the closer the fiber layer came to the heat exchanger module, the larger the discolored area grew.There was no visible thrombus formation on them.The outer cylinder was removed from the heat exchanger module and the inside of the heat exchanger module was subjected to visual inspection.No clot formation was observed.Electron microscopic inspection of the filter revealed the adhesion of the erythrocyte components on both surfaces.The discolored segment of the fiber on each layer was inspected under electron microscopy.There was no anomaly in the size of the micro pores on the outer surface of the fiber, with some micro pores having been plugged with blood plasma component.The partial adhesion of the erythrocyte components, including blood plasma and red blood cells, was found.The inside surface of the discolored segment of the fiber was inspected under electron microscopy.Most of the micro pores were found to have been plugged with blood plasma.A review of the device history record and product release decision control sheet of the involved product code/lot number combination revealed no findings.Ifu reference: 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 15l/min for 10 seconds.Do not repeat this flushing technique, even if oxygenator performance is not improved.There is no evidence that this event was related to a device defect or malfunction.During the investigation the actual device was found to have a plasma leak.As a cause of the reported decline in pao2, it is likely that the plasma leak hindered blood from having sufficient contact with oxygen gas, leading to the degradation of the gas transfer performance of the actual device.From the available information, however, it is difficult to determine the definitive cause of the declined pao2.As the cause of the plasma leak; experientially it was likely due to a change in the blood properties due to some factor(s), a surface-active substance may be generated in blood.This may lead 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 plasma leak.The exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).

Event Description

The user facility reported in the mvr case, cpb was initiated at 11:25.At 14:57, pao2 started to decline gradually and fio2 was increased to 70% from 60%.Around 16:18, pao2 started to decline again and fio2 was increased to 90% from 80% and then to 100%.These increases did not work and pao2 continued to decline.The actual sample was changed out.The amount of blood loss is unknown.The procedure was completed without any further issue.

• Brand Name: CAPIOX FX OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer Contact: mark vornheder ; reg. no. 2243441; 950 elkton blvd; elkton, MD 21921 ; 8002837866
• MDR Report Key: 7833154
• MDR Text Key: 118789067
• Report Number: 9681834-2018-00152
• 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: 08/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: CX-XRY53301
• Device Lot Number: 180523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2018
• Initial Date FDA Received: 08/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2018
• 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