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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER OXYGENATOR, CARDIOPULMONARY BYPASS

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TERUMO CORPORATION, ASHITAKA CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number CX*FX05RW
Device Problem Coagulation in Device or Device Ingredient (1096)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/07/2021
Event Type  Injury  
Manufacturer Narrative
Implanted date: device was not implanted. Explanted date: device was not explanted. Pma/510(k)- k130280. The actual sample was not available for the investigation. The image provided of the actual product showed a formation of glue-like clots. The blood level was considered to have been at least 400 ml or more based on the wet state of the defoamer of venous filter. 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 sates: adequate heparinization of the blood is required to prevent it from clotting in the system. The reservoir of this product is designed to stabilize the blood storage surface to make it easier to manage, on the other hand, blood is difficult to be agitated in the reservoir. Based on this characteristic and experience, it was likely that blood with activated coagulation factors flowed into the reservoir and stayed on the surface, leading to the formation of blood clots, and afterward, when the fluid level was lowered, the formation of clots was revealed. 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 and there was blood clotting. The product was checked, no abnormity was found. The operator found blood coagulation in the reservoir after ten mins of cpb. Act was over 500s before cpb start. The product was exchanged a new one. The patient was not harmed. The procedure outcome was not reported.
 
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Brand NameCAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER
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
950 elkton blvd.
elkton, MD 21921
8002837866
MDR Report Key12056324
MDR Text Key265815152
Report Number9681834-2021-00114
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K071572
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 06/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCX*FX05RW
Device Lot Number200604C
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 Received06/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/04/2020
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: 06/24/2021 Patient Sequence Number: 1
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