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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX05 OXYGENATOR, CARDIOPULMONARY BYPASS

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TERUMO CORPORATION, ASHITAKA CAPIOX FX05 OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number CX*FX05RW
Device Problem Leak/Splash (1354)
Patient Problem Blood Loss (2597)
Event Date 04/16/2020
Event Type  malfunction  
Manufacturer Narrative
Implanted date: device was not implanted. Explanted date: device was not explanted. Occupation- requested, not provided. 510(k) - k130280. 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. For a review of the device history record and the product release judgement control record of the involved product code/lot number combination revealed no findings. (b)(4).
 
Event Description
The user facility reported that the involved capiox device was used during the procedure. Surgical management of patient with regular tetralogy of fallot with persistent ductus arteriosus and hyper pulmonary flow in the context of poly malformative syndrome. At the time of the operation, a leak was observed at the outlet of the oxygenator from the extracorporeal circulation. They plugged the leak to successfully complete the operation. Risk of hypovolemia; patient blood loss was bout 70ml. There was no harm to the patient.
 
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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 Key10156896
MDR Text Key197351114
Report Number9681834-2020-00094
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
Type of Report Initial,Followup
Report Date 06/16/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2021
Device Catalogue NumberCX*FX05RW
Device Lot Number181031
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/27/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/31/2018
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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