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U.S. Department of Health and Human Services

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

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TERUMO CORPORATION, ASHITAKA CAPIOX FX25 OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number CX-XRX35920
Device Problem Infusion or Flow Problem (2964)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/04/2021
Event Type  malfunction  
Manufacturer Narrative
Udi - not required for product code. Implanted date: device was not implanted. Explanted date: device was not explanted. Occupation-clinical engineer. Pma/510(k)- k130520. The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted. 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. It is likely that blood clots were formed and clogged the cr filter due to blood with activated coagulation factors flowed into the reservoir; blood clots and tissue fragment sucked from the surgical field flowed into the reservoir, resulting in the clogging. However, with no device return the exact cause of the reported event cannot be definitively determined based on the available information. (b)(4).
 
Event Description
The user facility reported the capiox device was used during the procedure. It was a thoracic aorta case. In less than 30 minutes from the start of circulation, the cr filter of the reservoir rr40v clogged, the pressure at the cr part increased, and suction became impossible. Another rr40v was added and used as cr. It was connected to the 3/8 port next to the inlet port. The procedure outcome was not reported. The patient was not harmed.
 
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Brand NameCAPIOX FX25
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
265 davidson ave suite 320
somerset, NJ 08873
8002837866
MDR Report Key11357330
MDR Text Key238927661
Report Number9681834-2021-00015
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 02/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2022
Device Catalogue NumberCX-XRX35920
Device Lot Number201110
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 Received02/04/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/10/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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