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

Catalog Number CX-XRX13501

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 02/14/2020

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.510k - k130520.The actual sample was received for evaluation.Visual inspection revealed that blood was adhered between the red stopcock and the housing (transparent part).It was assumable that the leaked blood stuck to that area.No adhesion of blood was observed around the housing parts of the blue and yellow stopcocks.The actual sample after rinsed was subjected to visual inspection with ccd.No anomaly that could lead to the leak, such as a break, was observed in the blood channel of the red stopcock.X-ray fluoroscopic inspection of the red stopcock part revealed no anomaly in the fitting condition between the stopcock and the fastener pin.As a factor to lead to leak, no gap or no trapped foreign matter was found between the stopcock and the housing.The actual sample was filled with saline solution and pressurized at 1000mmhg.No leak was observed.Subsequently, the actual sample was pressurized at 1000mmhg each time the red stopcock was turned by 90-degrees.No leak was observed while the red stopcock was at any position.While the actual sample was pressurized at 1000mmhg, the red stopcock was turned 10 times each in the clockwise and counterclockwise directions.No leak was observed.Reproductive testing was performed.The actual sample was pressurized, the lever of the red stopcock was subjected to upward and downward force.As a result, leak occurred from the root of the lever.When the lever of the red stopcock was free from the said force, leak stopped.This reproductive test was performed with a factory retained current product sample.As a result, a leak was observed from the root of the lever.As a cause that leak occurred when the lever of the stopcock was subjected to external force in upward/downward directions, it is conceivable that a small gap was caused between the stopcock and the housing when the lever of the stopcock was exposed to such external force, and blood leaked through the gap.A review of the device history record and product release decision control sheet of the product code/lot# combination was conducted with no findings.Ifu states: do not use an oxygenator and reservoir that leaks.Replace it with another capiox fx25 oxygenator and reservoir.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.It is likely that the actual sample under the circulation pressure was subjected to external force on the lever of the red stopcock due to some factors.Due to this, gap was generated between the stopcock and the housing, and blood leaked through the gap.However, the exact cause of the reported event cannot be definitively determined based on the available information.Terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).

Event Description

The user facility reported that the involved capiox device was used during ecc.A leak was observed from the red switch cock on the sampling system.Since the red switch cock had nothing to do with the ecc, the ecc was continued and finished with no manipulation of the red switch cock.The amount of blood loss was reported to be unknown.There was no change-out of oxygenator.The procedure outcome was unknown, and the final patient impact 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; 265 davidson ave suite 320; somerset, nj ; 2837866718
• MDR Report Key: 9785535
• MDR Text Key: 224676652
• Report Number: 9681834-2020-00029
• 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: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: CX-XRX13501
• Device Lot Number: 191129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2019
• 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