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

Catalog Number	CX*RX25RE
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/18/2018
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 was returned for evaluation.Visual inspection upon receipt did found that the sampling line tube had been cut at the location adjacent to the blood outlet port on the oxygenator.It was also found that the blood inlet port on the reservoir had been partially cracked.There was no other anomaly on the remainders of the device.The actual sample was rinsed and dried.With the sampling line clamped, saline solution was filled in the blood phase.With the blood outlet port side clamped, an air pressure of 2kgf/cm2 was applied to the blood phase from the blood inlet port.No leak was confirmed.For better visibility, colored saline solution was used.The actual sample was built into a circuit with tubes and the circuit was primed with saline solution in accordance with the ifu instruction.There was no air remaining in the device.A bubble trap was built in the blood outlet port side so as to check any air going into the bubble trap and the oxygenator module.Bovine blood at 37 oc was circulated in the actual sample at the flow rate of 7l/min.No leak or no entrance of air was confirmed.With the blood flow rate kept at 7l/min., air was injected to the venous line positioned upstream the reservoir.The injected air did not flow out into the blood in the reservoir or to the oxygenator module.While bovine blood was being circulated in the actual device at the flow rate of 0.5l/min., an air of 0.5 - 20l/min.Was sent into the gas line.No entrance of air into the oxygenator module was confirmed.With the blood flow rate set at 7l/min., the level of the blood in the reservoir was decreased to 200ml, which is the minimum operating level of the rx25 reservoir.There was no entrance of air into the blood in the reservoir or into the oxygenator module.A review of the manufacturing record and the product release decision control sheet of the involved product/lot# combination was conducted with no findings.The ifu states: - do not obstruct gas outlet port.Avoid buildup of excess pressure in the gas phase to prevent gaseous emboli entering the blood phase.Pressure in the blood phase should always be higher than that in the gas phase to prevent gaseous emboli entering the blood phase.The gas flow rate should not exceed 20l/min.Excessive gas flow rate will bring about pressure increase in the gas phase, allowing gaseous emboli to enter the blood phase.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.When capiox rx25 oxygenator module is used separately from the hardshell reservoir, set the module so that the upper end of the fibers is lower than the blood level in the venous reservoir.This prevents gaseous emboli from entering the blood phase from the gas phase.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.There is no evidence that this event was related to a device defect or malfunction.The investigation result verified that the actual sample was the normal product.During the investigation, the reported event was not duplicated.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 the oxygenator during operation was not normal.A lot of bubble came out during bypass.They adjusted the gas flow, and used a defoaming agent to reduce the bubble.The procedure outcome and patient impact was reported to be unknown.

• 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: 7679281
• Report Number: 9681834-2018-00127
• Device Sequence Number: 1370541
• Product Code: DTZ
• UDI-Device Identifier: 04987350769558
• UDI-Public: 04987350769558
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K040210
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/11/2018

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: 171122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2018
• Initial Report FDA Received Date: 07/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1