• 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-FX05RW
Device Problem Insufficient Flow or Under Infusion (2182)
Patient Problem Blood Loss (2597)
Event Date 01/29/2019
Event Type  Injury  
Manufacturer Narrative
Implanted date: device was not implanted. Explanted date: device was not explanted. Pma/510(k): k130280. The actual device was received for evaluation. Visual inspection revealed no anomalies. The actual device was flushed with saline solution by gravity drop. Subsequent visual inspection did not find any clots visible with the naked eye. 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 the outer surface. Visual inspection of the oxygenator module, after the housing component and the filter having been removed from it, did not find any clots visible with the naked eye on it. 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. Visual inspection of each fiber layer did not find any clots visible with the naked eye. The outer cylinder was removed and the heat exchanger module was subjected to visual and magnifying inspections. No presence of a clot formation was confirmed. Magnifying inspection of the both sides of the filter removed from the oxygenator module confirmed no presence of clot formation. Magnifying inspection of the fiber layers removed from the oxygenator module confirmed no presence of clot formation. Electron microscopic inspection of the outer and inner surfaces of the filter removed from the oxygenator module revealed 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. The perfusion record from the involved procedure was reviewed and revealed the following: the values in pao2 and svo2 started to drop at the initiation of the circulation. At 12:06, pao2 started to increase with the increase in fio2 from 60% to 80% at the same time. After the increase in fio2, svo2 showed the tendency of increase. After the initiation of the circulation with the actual sample, pao2 stayed around 150mmhg, and started to increase after 12:23 when fio2 was increased from 80% to 90%. Following the gradual decrease in pao2 around 15:31, svo2 also started to decrease gradually. Around 15:42 when fio2 was increased gradually from 70%, svo2 stayed around 80%. Around 15:31 when svo2 started to decrease, the rate of rectal temperature rising started to increase. A review of the device history record of the involved product code/lot number combination revealed no findings. Ifu states: upon patient rewarming, adjust o2 concentration, gas flow rate and blood flow rate by increasing them as needed based on an increase in patient's metabolism. Failure to adjust the gas supply and the blood flow rate appropriately may cause insufficient o2 supply needed or the amount of the patient's gaseous metabolism. Measure blood gases and make necessary adjustments as follows. Control pao2 by changing concentration of oxygen in ventilating gas using gas blender. To decrease pao2, decrease fio2. To increase pao2, increase fio2. There is no evidence that this event was related to a device defect or malfunction. The investigation results verified the returned sample was of the normal product. Based on the investigation results, it is likely that rewarming of the patient activated his/her metabolism and the required o2 volume increased. This led svo2 to get decreased, resulting in the decrease in pao2. However, the exact cause of the reported event cannot be definitively determined based on the available information. This report is for the second device used, for the first device reported that was used on the same patient, see mdr 9681834-2019-00019. (b)(4).
 
Event Description
The user facility reported he circulation with the involved capiox started at 11:51 with fio2
=
60%. Due to po2 being 79mmhg, fio2 was increased to 80% at 12:06. Then po2 increased to the better level. As there was a possibility that the operation would be prolonged, the user decided to change out the actual sample to the second oxygenator. With the second oxygenator, they were not able to get the data they had expected. Doubting malfunction of the involved gas blender, they changed out the gas blender as well at 12:23. After that, they proceeded the operation with no gas transfer-related problem. At 15:46, when the clamp was released, the gas transfer performance was degraded. They completed the procedure with the second oxygenator and the patient was weaned off the bypass safely. The reported blood loss was 50ml. The procedure was completed successfully. The patient impact was reported to be unknown.
 
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
MDR Report Key8349571
MDR Text Key136604184
Report Number9681834-2019-00020
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 02/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2021
Device Catalogue NumberCX-FX05RW
Device Lot Number181009
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/31/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/29/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/09/2018
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: 02/19/2019 Patient Sequence Number: 1
-
-