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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-XRX52203
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/26/2018
Event Type  malfunction  
Manufacturer Narrative
Patient identifier - requested but not provided. Age & date of birth - requested but not provided. Sex - requested but not provided. Weight - requested but not provided. Ethnicity - requested but not provided. Race - requested but not provided. Udi - not required for the reported product code. Implanted date: device was not implanted. Explanted date: device was not explanted. The 510(k-) k130520. The actual device was returned for evaluation. Visual inspection revealed no anomalies. With the tubes connected to the actual device upon receipt kept as they were, priming was carried out by saline solution to run through the actual device. The actual device was primed in the normal manner with no occurrence of entrance of air into the device or of a leak at a tube joint. The actual device was filled with saline solution and pressurized with air at 2. 0kgf/cm2. No leak was confirmed. While the actual device was being circulated at the minimum flow rate of 0. 5l/min, air was sent inside the oxygenator module from the gas in-port at the maximum flow rate of 20l/min. There was no air coming out through the filter. The actual device was filled with saline solution. With the blood-out side and blood-in side being clamped, air was sent into the oxygenator module from the gas-in port and the pressure drop was determined. It was found to be equivalent to that of the factory-retained sample. The actual device was built into a circuit with tubes, and the pressure drop was determined at each flow rate and verified to meet the specifications. In order to check the presence of air, a bubble trap was added to the blood-out side in the circuit. Air was sent into the oxygenator module from the blood-in side gradually. At any of the flow rates, no air came out through the filter and no air was trapped in the babble trap. A review of the device history record from the reported product code/lot number combination was conducted with no findings. There is no evidence that this event was related to a device defect or malfunction. During the investigation the actual device did not pose any anomalies which would relate to the reported air entrainment into the device. (b)(4).
 
Event Description
The user facility reported in the case of selective cerebral perfusion, after the initiation of the extracorporeal circulation, while the cerebral perfusion was being proceeded, air was noted to have been pulled into the circuit. The procedure outcome and patient condition was reported to be 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 Key7444011
MDR Text Key106625482
Report Number9681834-2018-00053
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 04/19/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2019
Device Catalogue NumberCX-XRX52203
Device Lot Number171212
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/30/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/26/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/12/2017
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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