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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER OXYGENATOR, CARDIOPULMONARY BYPASS

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TERUMO CORPORATION, ASHITAKA CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number CX-FX05RE
Device Problem Increase in Pressure (1491)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/10/2021
Event Type  Injury  
Manufacturer Narrative
Implanted date: device was not implanted. Explanted date: device was not explanted. Occupation- clinical engineer. Pma/510(k)- k130280. The actual sample was received for evaluation. Visual inspection revealed no breakage or other anomaly in the appearance. The actual sample was built into a circuit with tubing, and normal saline was flowed by head. The flow rate of the normal saline flowing out from the actual sample was found lower than that from a current product, which suggested that a clogging had occurred. The oxygenation module of the actual sample was inspected visually, and a formation of fiber-like blood clots was confirmed. The actual sample was fixed by being filled with glutaraldehyde-containing normal saline, and then the housing and the filter were removed. Visual inspection of the oxygenation module found no formation of blood clots that could lead to the increasing pressure. The oxygenation module was visually inspected while the fiber layer was removed gradually. Formation of blood clots was observed on the fiber near the heat exchanger. No anomaly was noted in the winding state of fiber. The heat exchanger was removed from the outer cylinder and subjected to visual and magnifying inspections. Formation of white clots was observed. The filter and fiber were inspected under an electron microscope; formation of fibrin net and adhesion of red blood cells, deformed red blood cells (echinocyte), platelets and other blood cell components were observed. A review of the device history record and product-release judgement record of the involved product code/lot# combination was conducted with no findings. Ifu states: do not reduce heparin during circulation. Otherwise, blood clotting might occur. Adequate heparinization of the blood is required to prevent it from clotting in the system. 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 was likely that the cause of occurrence was conceivable to be the following factors because the clogging occurred 20 minutes after the start of circulation and the circulation temperature was lowered. The blood with activated aggregation of leukocytes and platelets might have flowed into the oxygenator and caused clogging of the oxygenator, resulting in the increasing pressure drop. The cold agglutination might have caused the blood flow to be obstructed and the pressure drop to increase. However, it was not possible to clarify the definite cause of activation of leukocyte and platelet aggregation and the cause of clogging. 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 was used during the procedure. The oxygenator pressure increased. Pressure increased in about 20 minutes after the pump was on. When the inlet pressure was 300 mmhg and the outlet pressure was 150 mmhg, they started to be a little concerned, increased the number of venous lines from one to two and increased the flow rate, and then checked the pressure again. The inlet pressure was 400 mmhg and the outlet pressure was 100 mmhg, so they replaced the actual sample with a new fx05 using a line for the oxygenator exchange. The procedure completed successfully. The patient was not harmed.
 
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Brand NameCAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER
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
mary o'neill
reg. no. 2243441
950 elkton blvd.
elkton, MD 21921
8002837866
MDR Report Key12949938
MDR Text Key282280691
Report Number9681834-2021-00225
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K071572
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCX-FX05RE
Device Lot Number210610
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/12/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/10/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/10/2021
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: 12/07/2021 Patient Sequence Number: 1
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