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

Catalog Number CX-CRY54601A

Event Date 05/13/2019

Event Type  malfunction  

Manufacturer Narrative

Expiration date - unknown due to unknown lot number.Udi - not required for product code.Implanted date: device was not implanted.Explanted date: device was not explanted.Device manufacture date - unknown due to unknown lot number.Pma/510k - k130520.The actual sample was received for evaluation.Visual inspection revealed adhesion of blood at the base of the red stopcock, implying that the reported leak occurred at the base of the red stopcock.Further visual inspection did not find any other anomaly, such as a break, on the remainders of the device.The actual sample was rinsed and the blood path inside the red stopcock was inspected under magnification.Any break, such as a crack, which could have been a trigger of the reported blood leak was not revealed.X-ray fluoroscopic inspection focusing on the red stopcock confirmed no anomaly in the state of the fitting between the stopcock component and the fastening pin.There was not any anomaly, such as a break or a jammed foreign particle, inside the component.The actual sample was filled with saline solution and the inside was pressurized at 1.0kgf/cm2.No leak was confirmed.The same pressurization test after the direction of the red stopcock had been changed did not cause any leak, either.With the pressurization to the inside of the actual sample kept at 1.0kgf/cm2, the red stopcock was turned ten times clockwise, then ten times counterclockwise.No leak was confirmed.The production lot number was not provided by the user facility, which prevented a meaningful review of the device history record.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.(b)(4).

Event Description

The user facility reported that during the extracorporeal circulation, blood leaked from the capiox sampling system.The customer continued using the actual sample without change-out and completed the procedure successfully.No harm on the patient has been confirmed.The volume of the lost blood was reported to be in a very small amount, less than 10ml.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide additional information and to provide the completed investigation.Results: 114 is based upon the evaluation of user facility information and the reproductive testing of the returned sample; 213 is based upon functional testing of the returned sample.Conclusion: 4310 is based upon evaluation of the user facility information and the reproductive testing of the returned sample; 67 is based upon functional testing of the returned sample.Ifu states: do not use an oxygenator and reservoir that leaks.Replace it with another capiox fx15 oxygenator and reservoir.Based off the additional information received, reproductive testing was performed; while the actual sample filled with saline solution was being pressurized, the red stopcock was subjected to upward and downward force.Saline solution was found to leak at the base of the red stopcock.The same test was conducted on the current product sample and the same result was obtained.As a cause of the occurrence of a leak at the base of the stopcock when the stopcock is subjected to force in the vertical direction, it is likely that a gap is generated between the housing and the stopcock and acts as a leak channel.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 red stopcock was exposed to some force due to some factor and a gap was generated between the stopcock and the housing.When the actual sample was subjected to the circulation pressure, blood leaked from the gap.However, the exact cause of the reported event cannot be definitively determined based on the state of the actual sample and the available information.

Event Description

Additional information obtained on june 11, 2019.The customer found the adhesion of blood at the base of the red stopcock on the sampling system, which made them realize that a leak had occurred at this component.It was not during the manipulation of the red stopcock that they found the presence of blood adhesion.When they found the trace of blood, the actual sample was not leaking and they continued to use the actual sample to the end of the procedure.The user always uses the red stopcock to sample blood.

• 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
• MDR Report Key: 8691016
• MDR Text Key: 147730041
• Report Number: 9681834-2019-00089
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K071494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/12/2019

1 Device was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CX-CRY54601A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• Initial Date Manufacturer Received: 05/14/2019
• Initial Date FDA Received: 06/12/2019
• Supplement Dates Manufacturer Received: 05/20/2019
• Supplement Dates FDA Received: 06/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No