• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

TERUMO CORPORATION, ASHITAKA CAPIOX FX OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number CX-FX15RW40V
Device Problem Coagulation in Device or Device Ingredient (1096)
Patient Problem Blood Loss (2597)
Event Date 01/31/2019
Event Type  Injury  
Manufacturer Narrative
Udi - not required for product code implanted date: device was not implanted. Explanted date: device was not explanted. Pma/510(k): k130520. The actual device was received for investigation. Visual inspection revealed some clots adhering to the cardiotomy filter (hereinafter called cr filter in this report) and the venous filter. There was not any visible obvious anomaly, such as a break, in the appearance. The reservoir was disassembled into each component. The cr filter and the defoamer were taken out of the cr filter, after having been rinsed in physiological saline solution, and were subjected to visual inspection. The presence of clots was noted on them. The venous filter and defoamer were taken out of the venous filter, after having been rinsed in physiological saline solution, were subjected to visual inspection. The presence of clots was found on the outer and inner surfaces. There were not any clots on the defoamer. The cr filter and defoamer were fixed with glutaraldehyde solution for further inspection. Electron microscopic inspection revealed the formation of the fibrin net, the adhesion of blood corpuscle components; including red blood cells and deformed red blood cells (echinocytes), on them. The venous filter and defoamer were fixed with glutaraldehyde solution for further inspection. Electron microscopic inspection revealed the formation of the fibrin net and the adhesion of blood corpuscle components, including red blood cells and deformed red blood cells (echinocytes), on them. The clots adhering to the surface of the venous filter were sampled. The electron microscope inspection of the clots revealed the formation of the fibrin net and the presence of blood corpuscle components, including red blood cells and deformed red blood cells(echinocytes). The oxygenator module was visually inspected with the naked eye and revealed no obvious anomalies. The actual device was flushed with saline solution by gravity drop. Subsequent visual inspection found the presence of some clots. The actual device was fixed with glutaraldehyde solution and the housing component and the filter were removed from the oxygenator module. Visual inspection of the filter removed from the oxygenator module found the formation of clots on both surfaces. Visual inspection of the oxygenator module, after the housing component and the filter having been removed from it, found the presence of some clots on the filter. There was no anomaly in the state of fiber winding. The fiber layers were removed from the winding in increments of 2 mm and each layer was subjected to visual inspection. Clots was found to have formed thinly on the surface of the fiber layers located on the upper and bottom sides near the heat exchanger module. The outer cylinder was removed and the heat exchanger module was subjected to visual and magnifying inspections; clot formation was not found. Magnifying inspection of the both sides of the filter removed from the oxygenator module revealed the formation of clots on the partial area on the outer surface. Magnifying inspection of the fiber layers removed from the oxygenator module did not reveal any clot formation on them. Electron microscopic inspection of the outer and inner surfaces of the filter removed from the oxygenator module revealed the formation of fibrin nets on them and the adhesion of blood corpuscle components, including red blood cells and deformed red blood cells (echinocytes), to them. Electron microscopic inspection of the upper segments of the fiber layers removed from the oxygenator module revealed the formation of fibrin nets on them and the adhesion of blood corpuscle components, including red blood cells, deformed red blood cells(echinocytes) and blood platelets, to them. A review of the device history record of the involved product code/lot number combination revealed no findings. The ifu states: adequate heparinization of the blood is required to prevent it from clotting in the system. Do not reduce heparin during circulation. Otherwise, blood clotting might occur. There is no evidence that this event was related to a device defect or malfunction. Based on the investigation, it is likely that the clots formed due to some factor(s) caused the reported rise in the pressure and drop in the flow rate. However, based off the available information the exact cause of the reported event cannot be definitively determined. (b)(4).
 
Event Description
The user facility reported that during the circulation of the involved capiox device, the operator noticed some clots formed inside the reservoir. Suddenly, the pressure before the membrane became high with a drop in the flow rate. Heparin was added and recirculation was carried out and the issues disappeared. The amount of blood loss and patient impact was reported to be unknown. The procedure was completed successfully.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
950 elkton blvd
elkton, MD 21921
8002837866
MDR Report Key8355324
MDR Text Key136742078
Report Number9681834-2019-00022
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 02/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2021
Device Catalogue NumberCX-FX15RW40V
Device Lot Number181029
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/04/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/31/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/29/2018
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: 02/20/2019 Patient Sequence Number: 1
-
-