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

Catalog Number	CX*RX25RE
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D6: implanted date: device was not implanted d7: explanted date: device was not explanted 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.For this reason, evaluation code 11 has been referenced in the conclusions section of h6.A review of the device history records and the product release decision control sheet of the involved product/lot# combination was conducted with no findings.A search of the complaint file found no other report of this nature with the involved product code/lot# combination.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.Exemption number e2015022.
Event or Problem Description
The user facility reported a flow restriction on the involved capiox device.The water level of the arterial line receded.The correct operation of the pump, the integrity of the filter and the lines were verified, finding them in good condition.In addition, bubbles were sealed inside the oxygenator.The procedure outcome is unknown.The patient was not harmed.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device return date in section d10 and to provide the completed investigation results.Visual inspection upon receipt revealed no defects.The actual sample was built into a circuit with tubes and saline solution was filled in it.After the occlusion of the roller pump was adjusted, the level of the solution in the arterial line tube downstream the oxygenator was set higher than that in the reservoir.This did not reproduce the reported abnormal drop in the solution level in the arterial line tube.Colored saline solution was used for better visibility.Subsequently, saline solution was circulated in the circuit by the roller pump at the flow rate of 7l/min.Any leak, including a leak at the tube joint, was not observed.The oxygenator module was removed from the circuit and its blood phase was filled with saline solution.With the blood outlet port side clamped, an air pressure of 2kgf/cm2 was applied to the blood phase from the blood inlet port side, while the oxygenator being observed for any leak.No leak was confirmed.Function testing was conducted.While the actual oxygenator module sample was being circulated with saline solution with the use of a roller pump, the roller pump was stopped suddenly.Air was found to be being pulled into the oxygenator module.Note: the negative pressure the oxygenator is exerted varies depending on the circulation conditions and/or the circuit specifications.The investigation result verified that the actual sample was the normal product with no anomaly related to a leak.The cause of the reported issue that the water level of the arterial line reduced cannot be determined.As a cause of the report that bubbles were sealed inside the oxygenator, it is assumable that the pressure inside the blood phase became lower than that inside the gas phase, due to which air was pulled inside the oxygenator module through the fibers.From the available information, however, the exact cause of the reported event cannot be definitively determined based on the available information.The ifu states: "during recirculation, do not use pulsatile flow and do not stop the blood pump suddenly as these actions may cause gaseous emboli to enter the blood phase from the gas phase due to inertia force.To prevent gaseous emboli from entering the blood phase, make sure that the arterial pump flow rate always exceeds the flow rate of the cardioplegia line.The blood flow rate of the cardioplegia line should not exceed 1l/min.

• Brand Name: CAPIOX RX OXYGENATOR
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• MDR Report Key: 7556187
• Report Number: 9681834-2018-00088
• Device Sequence Number: 11187061
• Product Code: DTZ
• UDI-Device Identifier: 04987350769558
• UDI-Public: 04987350769558
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K040210
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: CX*RX25RE
• Device Lot Number: 171111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/09/2018
• Supplement Date Received by Manufacturer: 06/13/2018
• Initial Report FDA Received Date: 05/31/2018
• Supplement Report FDA Received Date: 06/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1