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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 CX*FX25E
Device Problem Device Operational Issue (2914)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/14/2018
Event Type  Injury  
Manufacturer Narrative
Implanted date: device was not implanted. Explanted date: device was not explanted. Device manufacture date - unknown due to unknown lot number. 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. The production lot number was not provided by the user facility, which prevented a meaningful review of the device history record. (b)(4).
 
Event Description
The user facility reported during a cardiopulmonary bypass they had a failure with the pump on the involved capiox oxygenator. They went on bypass and immediately saw no color change and the venous stats were dropping. They went off bypass within a minute of going on bypass, they initially thought the isoflurane was blocking the oxygen. They went on bypass and recirculated the blood for a few minutes and did a gas. The p02 was 56, they repeated it and the p02 only went up to 82. They decided it was the oxygenator and changed it out. They did a gas, and the p02 was over 800. There was a four-minute delay. There was no blood loss. The product was changed out and 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, shizuoka 418
JA 418
Manufacturer (Section G)
TERUMO CORPORATION, ASHITAKA
reg. no. 9681834
150 maimaigi-cho
fujinomiya city, shizuoka 418
JA 418
Manufacturer Contact
terry callahan
reg. no. 2243441
950 elkton blvd.
elkton, MD 21921
8002837866
MDR Report Key7645807
MDR Text Key112586975
Report Number9681834-2018-00120
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
Type of Report Initial,Followup
Report Date 06/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2021
Device Catalogue NumberCX*FX25E
Device Lot Number180301
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/10/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/10/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2018
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: 06/28/2018 Patient Sequence Number: 1
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