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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER OXYGENATOR, CARDIOPULMONARY BYPASS

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TERUMO CORPORATION, ASHITAKA CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 1CX*FX05RW
Device Problem Coagulation in Device or Device Ingredient (1096)
Patient Problem Blood Loss (2597)
Event Date 05/12/2020
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. This report is for the second device reported, for the first device reported that was used on the same patient see mdr 9681834-2020-00093. (b)(4).
 
Event Description
The user facility reported that the involved capiox hemoconcentrator clotted off during cardiopulmonary bypass. There was no delay with the procedure due to the event. Surgery was completed successfully with little loss of blood (under 100 cc's). Due to both hemo and oxy clotted, the patient was asked if they had any underlying issue and they said no; however, they did give donor blood. The patient was reported to be fine. It started up with the hemoconcentrator, it clogged up and was changed out before going on bypass. When they were trying to go on bypass, the oxygenator clotted off. They changed out he oxygenator and the reservoir. All throughout the case, they noticed a huge buildup of clot form in the venous sat. There was no injury to the patient.
 
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Brand NameCAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER
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 
2837866718
MDR Report Key10111054
MDR Text Key193427377
Report Number9681834-2020-00092
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K071572
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 06/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1CX*FX05RW
Device Catalogue NumberCX*FX05RW
Device Lot Number200124
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/04/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/04/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/24/2020
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: 06/02/2020 Patient Sequence Number: 1
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