• 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 FX05 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 FX05 OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number CX*FX05RE
Device Problem Gas Leak (2946)
Patient Problem Air Embolism (1697)
Event Date 04/19/2020
Event Type  malfunction  
Manufacturer Narrative
Patient identifier - requested, not provided. Date of birth - requested, not provided. Weight - requested, not provided. Ethnicity - requested, not provided. Race - requested, not provided. Implanted date: device was not implanted. Explanted date: device was not explanted. 510(k) - k130280. The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted. The production lot number was not provided by the user facility, which prevented a meaningful review of the device history record. Ifu states: during recirculation, do not use pulsatile flow and do not stop the blood pump suddenly as these actions may cause gaseous emboli to enter the blood phase from the gas phase. Do not obstruct gas outlet port. Pressure in the blood phase should always be higher than that in the gas phase. The gas flow rate should not exceed 5l/min. Excessive gas flow rate will bring about pressure increase in the gas phase. To prevent gaseous emboli from entering the blood phase, make sure that the arterial pump flow rate always exceeds the flow rate of the cardioplegia line. The blood flow rate of the cardioplegia line should not exceed 0. 5l/min. Total flow rate of the arterial line and any separate arterial lines must not exceed the flow rate at the oxygenator inlet port. When capiox fx05 oxygenator module is used separately from the hardshell reservoir, set the module so that the upper end of the fibers is lower than the blood level in the venous reservoir. This prevents gaseous emboli from entering the blood phase from the gas phase. With no return of the actual device, the exact cause of the reported event cannot be definitively determined based on the available information. Terumo medical products (tmp) (importer) registration no. (b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no. (b)(4).
 
Event Description
The user facility reported that the involved capiox device was used during the procedure. The patient was a victim of an anesthetic accident (gas embolism) during heart surgery, and she has since suffered serious neurological after-effects. The extracorporeal circulation circuit (artificial respirator) would be implicated; his equipment consists of a pump (by livanova) and a circuit (terumo). The perfusionist of this hospital reported that they did not report this event at the time of the event, they mentioned that the device was not defective, a human error has occurred. The procedure outcome was not reported. The patient was harmed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCAPIOX FX05
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
265 davidson ave suite 320
somerset, nj 
2837866718
MDR Report Key10256600
MDR Text Key202986438
Report Number9681834-2020-00125
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeFR
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 07/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCX*FX05RE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/16/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-