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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX25 OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS

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TERUMO CORPORATION, ASHITAKA CAPIOX FX25 OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number CX*FX25RW
Device Problems Decrease in Pressure (1490); Increase in Pressure (1491)
Patient Problem No Information (3190)
Event Date 02/13/2020
Event Type  Injury  
Manufacturer Narrative
Patient identifier - (b)(6). Implanted date: device was not implanted. Explanted date: device was not explanted. Pma/510(k)- k130520. The actual device has not been returned for evaluation. The investigation is currently ongoing. A follow up report will be submitted once the investigation is complete. A review of the device history record and product release decision control sheet of the involved product code/lot# combination was conducted with no findings. (b)(4).
 
Event Description
The user facility reported that the involved capiox device was used during the procedure. They started the surgical procedure; interarticular communication without apparent incidents. They proceeded to administer heparin, and performed aortic cannulation without incident, without pressure gradients between mean blood pressure and aortic pressure. Both cavas, left cavities and aortic root without mishaps are cannulated. Dcp was started without apparent incidents, the aorta was clamped and cardioplegia administration of the nest began, just at that moment when the cardioplegia was being administered the centrifugal machine stopped. The mean arterial pressure dropped, and the presence of air is detected in the venous line on its way. At that time, it was decided to perform circulatory arrest with cerebral protection at 32 degrees which was the current temperature of the patient (ice is placed on the patient's head, medications are administered for brain protection). It was decided to change the centrifuge, thinking that it was the machine that failed first intention. However, no favorable results were obtained. They changed from centrifuge to rollers, without favorable results. The oxygenator was changed, it was primed with the volume recovered from the first oxygenator, the circuit is recirculated and the dcp is restarted, recovering cardiac output and continuing with the perfusion protocol established for the patient. It is observed that even with the change of oxygenator there was pressure greater than 360 in the measurement line of the aortic pressure, so it was excluded to avoid damage and dissection of the same; immediately the doctor is notified. The procedure was completed successfully. At the end of the dcp, functionality of both centrifugal machines was checked without any problem. Therefore, the malfunction of them was ruled out. The final patient impact was not reported.
 
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Brand NameCAPIOX FX25 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 
2837866718
MDR Report Key9797376
MDR Text Key196403498
Report Number9681834-2020-00032
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeMX
PMA/PMN Number
K071494
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCX*FX25RW
Device Lot Number190924K
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/23/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/23/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/24/2019
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: 03/06/2020 Patient Sequence Number: 1
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