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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX 15 HOLLOW FIBER OXYGENATOR AF OXYGENATOR, CARDIOPULMONARY BYPASS

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TERUMO CORPORATION, ASHITAKA CAPIOX FX 15 HOLLOW FIBER OXYGENATOR AF OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number CX*FX15E
Device Problem Infusion or Flow Problem (2964)
Patient Problem Blood Loss (2597)
Event Date 09/05/2019
Event Type  Injury  
Manufacturer Narrative
Implanted date: device was not implanted. Explanted date: device was not explanted. 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. Terumo medical products (tmp) (importer) registration no. (b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no. (b)(4).
 
Event Description
The user facility reported that during cardiopulmonary bypass, the capiox device failed to oxygenate after removing the cross plant. The product was changed out and the surgery was completed successfully. The reported event did not cause a delay with continuing the procedure. There was 150ml blood loss as result; there was no injury due to the event.
 
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Brand NameCAPIOX FX 15 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
theresa mussaw
reg. no. 2243441
950 elkton blvd.
elkton, MD 21921
8002837866
MDR Report Key9139578
MDR Text Key166933807
Report Number9681834-2019-00170
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 company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2021
Device Model NumberCX*FX15E
Device Catalogue Number1CX*FX15E
Device Lot Number180809
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/09/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/09/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/09/2018
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: 10/01/2019 Patient Sequence Number: 1
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