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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-XRX53401
Device Problem Device Operational Issue (2914)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/18/2018
Event Type  malfunction  
Manufacturer Narrative
Udi #- not required for product code. Implanted date: device was not implanted. Explanted date: device was not explanted. Pma/510(k): k130520. The actual device has been returned for evaluation. Visual inspection revealed no anomalies. The actual sample, after having been rinsed and dried, was tested for its gas transfer performance in accordance with the factory's shipping inspection protocol. No anomalies were revealed in the gas transfer performance of the actual sample, and met factory specifications. A review of the device history record and product release decision control sheet of the involved product code/lot number combination revealed no findings. Ifu states: - measure blood gases and make necessary adjustments as follows. B. Control paco2 by changing the total gas flow. To decrease paco2, increase total gas flow. To increase paco2, decrease total gas flow. The investigation result verified that the actual sample, after having been rinsed, was the normal product with no issue in the gas transfer performance. With no information about the events leading up to the complaint not available, the exact cause of the reported event cannot be definitively determined based on the available information. (b)(4).
 
Event Description
The user facility reported the co2 could not be removed with the gas flow rate of 10l/min. The presence of gas flow was confirmed, which indicated there was no problem with the blender. Vco2 was also high. The procedure outcome was unknown, and there was no harm on the patient.
 
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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
950 elkton blvd.
elkton, MD 21921
8002837866
MDR Report Key7517671
MDR Text Key108359185
Report Number9681834-2018-00081
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 Date08/31/2019
Device Catalogue NumberCX-XRX53401
Device Lot Number180307
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/23/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/19/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/07/2018
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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