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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-XRY32002
Device Problem Device Operational Issue (2914)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/13/2018
Event Type  malfunction  
Manufacturer Narrative
Implanted date: device was not implanted. Explanted date: device was not explanted. A 510k - k130520. The actual device was returned for evaluation. Visual inspection and x-ray fluoroscopic inspection revealed no anomalies. The actual sample was checked in accordance with the specification test method for the state of back-flow of air into the inside of the one-way valve by applying a specified air pressure (368mmhg) to the exit side of the one-way valve from the outside of the valve. No back-flow of air going inside the valve was confirmed. The actual device was built into the circuit. Saline solution was filled by using a centrifugal pump. The level of the fluid level in the sampling line was observed when the pump was stopped. No drop was observed in the fluid level. After the test, the sampling system was released. The customer's observation was confirmed. The fluid level in the sampling line started to lower gradually. Approximately 80mmhg (
=
the gravity/head pressure the exit side of the one-way valve is subjected to when the sampling line is filled with saline solution) was applied to the exit side of the actual device, while saline solution was circulated in the circuit at the flow rate of 0. 5l/min (the minimum blood flow rate). No drop was observed in the fluid level in the sampling line. From this it is most likely that the fluid level in the sampling line will not lower with the presence of a circulation pressure. The actual device was filled with saline solution with the fluid level set at 1-meter-high from the one-way valve (the height which generates approx. 80mmhg of gravity/head pressure on the one-way valve). After 5 minutes, the fluid level was found to have lowered by 6cm. The same test was conducted on 40 factory-retained one-way valves, the units passed. The degree of the lowered fluid level of the actual sample was verified to be within the variation among the 40 samples. A review of the device history record and the product release decision control sheet of the reported product code/lot number combination was conducted with no findings. The ifu states: set stopcocks, and close sampling line with arterial side stopcock to prevent arterial to venous shunting during extracorporeal circulation. There is no evidence that this event was related to a device defect or malfunction. During the investigation it was found that the fluid level in the sampling line could lower when the sampling system was released. This product has the structure where the slit of the valve closes air tightly when the exit side of the one-way valve is exposed to a pressure. A low pressure like gravity/head pressure may fail to lead the slit to close air tightly and a fluid may flow out into the entrance side of the one-way valve. (b)(4).
 
Event Description
The user facility reported when the set-up of the circuit was completed and the pump was stopped, the customer found that the fluid level in the sampling line leading to the sampling system was gradually lowering. Doubting a leak of the valve, the customer pressurized the exit side of the actual sample with a syringe to check, and they still saw the same issue. The patient condition and procedure outcome is unknown.
 
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Brand NameCAPIOX FX OXYGENATOR
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
2101 cottontail ln.
somerset, NJ 08873
8002837866
MDR Report Key7517672
MDR Text Key108363900
Report Number9681834-2018-00068
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
Type of Report Initial
Report Date 05/16/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2019
Device Catalogue NumberCX-XRY32002
Device Lot Number170925
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/19/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/16/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/25/2017
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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