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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-XRX43002A
Device Problem Leak/Splash (1354)
Patient Problem Blood Loss (2597)
Event Date 09/20/2019
Event Type  Injury  
Manufacturer Narrative
510k: k130520. The actual sample was received for evaluation. Visual inspection revealed no visible anomaly including a break in it. As a result of blowing air into the gas channel, liquid was observed on the gas outlet side. The liquid was collected and checked with terumo's protein test paper. Presence of protein was confirmed in the liquid. The liquid was centrifuged. As a result, no sedimentation of blood cell components was found in the liquid. The actual sample was built into a circuit. Physiological saline solution was circulated in the circuit, while the pressure drop was determined at each flow rate. The obtained values were confirmed to be slightly higher than those obtained from a current product sample. Review of the pump record did not find any indication that could lead to the plasma leak. After the actual sample was rinsed. The fiber from the outer and inner layer was inspected under electron microscope. There was no difference in the state of micro pore between the actual sample and a current product sample. 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: 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 20l/min for 10 seconds. Do not repeat this flushing technique, even if oxygenator performance is not improved. 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. It is likely that due to a change in the blood properties 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, and the fibers got hydrophilized, resulting in plasma leak; or the pressure inside the oxygenator module raised by some factors, such as clotting, may cause the pressure applied from the blood channel to the gas channel to get increased, this may create the circumstances where force to push the blood corpuscle components out into the gas phase may increase and plasma component could easily leak out through the micro pores on the surface of the fibers to the gas channel. However, the exact cause of the reported event cannot be definitively determined based on the available information. (b)(4).
 
Event Description
The user facility reported the involved capiox custom pack was used during a thoraco-abdominal vascular replacement case. A plasma leak occurred when ecc time exceeded six hours. The gas transfer performance dropped; the pressure at the outlet port of oxygenator increased. They replaced the device with a cx-fx25rw40v to complete the ecc. Estimated blood loss was 260ml. The actual sample was changed out. The patient was not harmed. The procedure outcome was not reported.
 
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Brand NameCAPIOX FX OXYGENATOR
Type of DeviceOXYGENATOR, 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
2101 cottontail ln.
somerset, NJ 08873
8002837866
MDR Report Key9207140
MDR Text Key173807296
Report Number9681834-2019-00175
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 10/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2020
Device Catalogue NumberCX-XRX43002A
Device Lot Number190603
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/24/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/20/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/03/2019
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: 10/18/2019 Patient Sequence Number: 1
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