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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-XRX55104
Device Problem Leak/Splash (1354)
Patient Problems Blood Loss (2597); No Known Impact Or Consequence To Patient (2692)
Event Date 07/06/2018
Event Type  Injury  
Manufacturer Narrative
Implanted date: device was not implanted. Explanted date: device was not explanted. The 510(k): k130520. The actual device was returned for evaluation. Visual inspection upon receipt found that the total area of the fiber had been discolored into black. A liquid red in color was noted to be pooled inside the housing on the gas-in side. No obvious break or deformity was found on the device. The liquid pooled inside the housing on the gas-in side was collected and the gas pathway was swept with air. As the result, some liquid was found to flow out of the gas pathway. Both of the collected liquids were centrifuged. For both, some deposits white in color were generated. The deposits were collected for further inspection. Based on the electron microscopic inspection findings, it is most likely that the deposits were not the erythrocyte components but some microbes multiplied during the transportation back to the factory for evaluation. From this, it is likely that it was only blood plasmas that leaked out of the actual device. The actual device, after having been rinsed, was filled with colored saline solution. With the blood-out port clamped an air of 2. 0kgf/cm2 was sent to the actual device from the blood-in port. No leak was confirmed. A review of the device history record of the product code/lot# combination was conducted with no findings. Ifu states: a phenomenon called wet lung may occur when water condensation occurs inside fibers of microporous membrane oxygenators with blood flowing exterior to the fibers. This may occur when oxygenators are used for a longer period of time. If water condensation and/or a decrease in pao2 and/or an increase in paco2 is noted during extended oxygenator use, briefly increasing the gas flow rate may improve the performance. Increase gas flow rate, to 20 l/min for 10 seconds. Do not repeat this flushing technique, even if oxygenator performance is not improved there is no evidence that this event was related to a device defect or malfunction. The investigation result verified that the actual device was the normal product with no anomaly which could have caused a leak. A plasma leak may have occurred. As a cause of a plasma leak, the provided factor can be inferred experientially. Due to a change in the blood properties due to some factor(s), a surface-active substance may be generated in blood. This may lead the balance of the surface tension between the gas and blood which is kept at the micro pores on the surface of the fibers to be upset, resulting in plasma leak. The exact cause of the reported event cannot be definitively determined based on the available information. (b)(4).
 
Event Description
The user facility reported around two hours after the initiation of the circulation with the involved capiox device, the customer noticed that a liquid was leaking out of the actual sample. With no occurrence of an obvious issue, he kept using it for a while. Due to the deterioration of the gas transfer performance and increased leak noted, the whole circuit was changed out. The amount of blood loss was reported to be unknown.
 
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Brand NameCAPIOX FX OXYGENATOR
Type of DeviceOXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
TERUMO CORPORATION, ASHITAKA
150 maimaigi-cho
fujinomiya city, shizuoka 418
JA 418
Manufacturer (Section G)
TERUMO CORPORATION, ASHITAKA
reg. no. 9681834
150 maimaigi-cho
fujinomiya city, shizuoka 418
JA 418
Manufacturer Contact
mark vornheder
reg. no. 2243441
2101 cottontail ln.
somerset, NJ 08873
8002837866
MDR Report Key7734380
MDR Text Key115523571
Report Number9681834-2018-00137
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K071494
Number of Events Reported1
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 07/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/31/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2019
Device Catalogue NumberCX-XRX55104
Device Lot Number180301
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/12/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/10/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/31/2018 Patient Sequence Number: 1
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