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U.S. Department of Health and Human Services

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

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TERUMO CORPORATION, ASHITAKA CAPIOX FX25 HOLLOW FIBER OXYGENATOR AF OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number 1CX*FX25E
Device Problem Infusion or Flow Problem (2964)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/14/2021
Event Type  malfunction  
Manufacturer Narrative
Implanted date: device was not implanted. Explanted date: device was not explanted. Occupation- perfusion director. 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 capiox device oxygenator has oxygenation issues. The issue occurred during cardiopulmonary. There was no delay, the product was not changed out, no blood loss and no adverse event reported. The surgery was completed successfully.
 
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Brand NameCAPIOX FX25 HOLLOW FIBER OXYGENATOR AF
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 Key12729330
MDR Text Key279587632
Report Number9681834-2021-00198
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K071494
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number1CX*FX25E
Device Lot Number200213
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/24/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/24/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/13/2020
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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