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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-XRY53702
Device Problem Increase in Pressure (1491)
Patient Problem Blood Loss (2597)
Event Date 05/07/2020
Event Type  Injury  
Manufacturer Narrative
Implanted date: device was not implanted explanted date: device was not explanted pma/510k: 510k - k130520. The actual sample was received for evaluation. Visual inspection revealed no obvious anomalies, such as a break, in the appearance. Physiological saline solution was flowed into the actual sample, blood channel was inspected visually. No formation of blood clots was observed. The actual sample before rinsed was built into a circuit with tube, and then physiological saline solution was circulated in the blood channel, while the pressure drop was determined at each flow rate. The obtained values were confirmed to be equivalent to that obtained from a current product sample. The actual sample was rinsed, dried, and bovine blood (hb12g/dl and temp. 37oc) was circulated in the circuit, while the pressure drop was determined at each flow rate. The obtained values were confirmed to meet the manufacturer specifications. No obstruction was confirmed. A review of the device history record and the product release decision control sheet of the involved product code/lot# combination was conducted with no findings. Ifu states: do not reduce heparin during circulation. Otherwise, blood clotting might occur. Adequate heparinization of the blood is required to prevent it from clotting in the system. Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction. The investigation results verified the returned sample was of the normal product. The exact cause of the reported event cannot be definitively determined based on the available information. (b)(4).
 
Event Description
The user facility reported that the capiox custom pack was used during the procedure. Blood in surgical field was sucked; it seemed that recirculation was performed to concentrate blood. (act was about 400 at the beginning). Due to the preparation on the operative field side, it took long time until the pump was on. After the pump started, the flow rate increased up to the half of the target level; however, would not increase further. Increasing pressure (over 300 mmhg) was also observed in the oxygenator. Since it was just after the pump started, they interrupted and replaced it with fx25e. Blood loss was 300 ml. The procedure was completed successfully. The patient impact 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
theresa mussaw
reg. no. 2243441
265 davidson ave suite 320
somerset, nj 
2837866718
MDR Report Key10104570
MDR Text Key193012555
Report Number9681834-2020-00077
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K071494
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2021
Device Catalogue NumberCX-XRY53702
Device Lot Number191213
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/13/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/08/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/13/2019
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: 06/01/2020 Patient Sequence Number: 1
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