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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-FX05RW
Device Problem Increase in Pressure (1491)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/13/2019
Event Type  malfunction  
Manufacturer Narrative
Udi - not required for product code. Implanted date: device was not implanted. Explanted date: device was not explanted. 510(k) no: k130280. The actual device was received for evaluation. Visual inspection revealed no anomalies such as a break in the visual appearance. The patient's blood was sampled from the inside of the actual device and the number of blood cells were counted by blood cell analyzer. It was found that the amount of hb and the number of red blood cells were low, whereas the numbers of white blood cells and platelets were high. Saline solution was let to flow through the actual device by gravity. Another visual inspection did not find any clot formation visible with the naked eye. The actual device was built into a circuit with tubes. Saline solution was circulated in it and the pressure drop was determined at each flow rate. The pressure drop of the actual device was found to be higher than that of the current product sample. The actual device was filled with saline solution containing glutaraldehyde solution to be fixed and the housing component and filter were removed. Visual inspection of the outer and inner surfaces of the filter did not find any clot formation visible with the naked eye. Visual inspection of the oxygenator module did not find any clot formation visible with the naked eye. The state of the fiber winding was confirmed to be normal. The fiber layer was removed from the winding in increments of 2mm and each layer was subjected to visual inspection. There was no clot formation on the fiber layers visible with the naked eye. The outer cylinder was removed from the heat exchanger module and the inside of the heat exchanger module was subjected to visual and magnifying inspections. White thrombi were found to have formed on it. The outer and inner surfaces of the filter removed were inspected under magnification. There was no clot formation on them. The diameters of the mesh were confirmed to be normal. The fiber layers removed were inspected under magnification. White thrombi were found to have formed on it. Electron microscopic inspection of the outer and inner surfaces of the filter revealed the adhesion of the blood corpuscle components, including blood platelets and red blood cells. Electron microscopic inspection of the fiber on each layer revealed the adhesion of the blood corpuscle components, including blood platelets, red blood cells and echinocyte and the formation of fibrin net. Electron microscopic inspection of white thrombi formed on the heat exchanger revealed the adhesion of the blood corpuscle components, including blood platelets and white blood cells. Reproductive testing was performed using a current product code of the involved product code, to duplicate the pressure rise the customer had experienced. The current oxygenator sample was built into the circuit with a reservoir and tubes. The pressure before the membrane of the sample was determined with the values of hb, the arterial temperature and the arterial flow rate arranged to be close to those indicated in the perfusion record and with the back pressure arranged so as for the pressure after the membrane to be almost the same as that indicated in the perfusion record. A review of the device history record of the product code/lot# combination was conducted with no findings. The perfusion record was reviewed: the arterial flow rate at 9:01 was 46ml/kg/min. This indicates that the customer implemented the stand-by circulation for around three hours before the extracorporeal circulation; the pressure after the membrane was around 9 -18mmhg and that before the membrane was around 6 -17mmhg. There was no change in the pressure drop. From this, it is likely that the there was no obstruction occurred in the actual device during the stand-by circulation; at 12:35, when the extracorporeal circulation was initiated, the pressure before the membrane started to rise; at 12:53 the pressure before the membrane rose up to 300mmhg's. After that, till the circulation was ceased, the pressure stayed between the latter half of 300mmhg's and the first half of 400mmhg's. The perfusion record shows that the pressure before the membrane started to rise significantly immediately after the initiation of the extracorporeal circulation. From this it is likely that the actual device started to be obstructed immediately after the initiation of the circulation, leading to the reported pressure rise. Ifu states: adequate heparinization of the blood is required to prevent it from clotting do not reduce heparin during circulation. Otherwise, blood clotting might occur. Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction. Based on the reproductive test result, it is likely that the actual device started to become obstructed at the initiation of the extracorporeal circulation. During the investigation, the formation of white thrombi consisting of blood platelets and white blood cells was revealed. Based on the provided information, the value of the patient's blood platelets was high. It is likely that due to some factor(s), blood in which the ability of aggregate platelets had become high flowed into the actual device, resulting in the formation of white thrombi and the reported rise in the pressure. 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 that the capiox device pressure before membrane stayed high at around the latter half of 300mmhg's - the first half of 400mmhg's from the beginning to the end of the procedure. There was no problem in the gas transfer performance. The actual device was not 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
950 elkton blvd
elkton, MD 21921
4103927866
MDR Report Key8975006
MDR Text Key157856399
Report Number9681834-2019-00158
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K071572
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 09/09/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/09/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2022
Device Catalogue NumberCX-FX05RW
Device Lot Number190401
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/19/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/13/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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