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U.S. Department of Health and Human Services

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

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TERUMO CORPORATION, ASHITAKA CAPIOX FX OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number CX*FX15RE40
Device Problem Infusion or Flow Problem (2964)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/08/2021
Event Type  Injury  
Manufacturer Narrative
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 judgement record of the involved product code/lot# combination was conducted with no findings. (b)(4).
 
Event Description
The user facility reported that the capiox device was used during the procedure. After initialization extracorporeal circulation with fx oxygenator, the perfusionist detected that the oxygenator's oxygen exchange capability was lost. After changing new fx oxygenator, the open-heart surgery case was done well with good oxygenator's oxygen exchange capability. The patient was not harmed. The procedure outcome was not reported.
 
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Brand NameCAPIOX FX 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
mary o'neill
reg. no. 2243441
265 davidson ave suite 320
somerset, NJ 08873
8002837866
MDR Report Key12073881
MDR Text Key258597883
Report Number9681834-2021-00115
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeVM
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
Report Date 06/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCX*FX15RE40
Device Lot Number200623
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/01/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/01/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/23/2020
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: 06/28/2021 Patient Sequence Number: 1
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