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U.S. Department of Health and Human Services

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

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TERUMO CORPORATION, ASHITAKA CAPIOX FX OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
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.
 
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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 Key8691016
MDR Text Key147730041
Report Number9681834-2019-00089
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
PMA/PMN Number
K071494
Number of Events Reported1
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 NumberCX-CRY54601A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/20/2019
Initial Date Manufacturer Received 05/14/2019
Initial Date FDA Received06/12/2019
Supplement Dates Manufacturer Received05/20/2019
Supplement Dates FDA Received06/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
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