MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX15; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number	CX*FX15RW30
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.Pma/510(k)- k130520.The actual device has been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.A review of the device history record and product release decision control sheet of the involved product code/lot number combination was conducted with no findings.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 that the involved oxygenator cx*fx15rw30 was leaking during use; it was found during priming; blood lost was not related to the reported event.The actual sample was changed out.The event occurred pre-treatment; there was no patient involvement, the patient outcome and patient condition was not available.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to update and to provide the completed investigation results.The actual device was received for evaluation.Visual inspection revealed that the three-way valve attached by the customer to the venous blood inlet port on the reservoir had been broken.On the remainders of the actual sample, there was not any other obvious anomaly, such as a break, in the appearance.The broken three-way stopcock was replaced with a factory-retained yellow cap.The actual sample was, then, built into a circuit with tubes and saline solution was circulated in it.No leak was observed.Subsequently, the blood phase of the oxygenator module 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.No leak was observed.Then, the water phase of the heat exchanger housed in the oxygenator module was filled with water.With the water outlet port side clamped, an air pressure of 3kgf/cm2 was applied to the water phase from the water inlet port.No leak was observed.Colored water was used for better visibility of the behavior of the solution.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.The investigation results verified the returned sample was of the normal product.The exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: CAPIOX FX15
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 8763914
• Report Number: 9681834-2019-00113
• Device Sequence Number: 1489668
• Product Code: DTZ
• UDI-Device Identifier: 04987350701169
• UDI-Public: 04987350701169
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K071494
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2019

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: 03/31/2021
• Device Catalogue Number: CX*FX15RW30
• Device Lot Number: 180425C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2019
• Initial Date Received by Manufacturer: 06/12/2019
• Supplement Date Received by Manufacturer: 06/27/2019
• Initial Report FDA Received Date: 07/05/2019
• Supplement Report FDA Received Date: 07/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 3 YR