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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-FX25RW
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/07/2018
Event Type  malfunction  
Manufacturer Narrative
The 510k - k130520. The actual device along with the thermistor code was returned for evaluation. Visual inspection revealed no anomalies. The actual device was rinsed and dried. The thermistor probe and thermistor code were inspected fluoroscopically under x-ray; revealing no anomalies were found. The response of the actual device to a temperature was compared with that of the retention sample, revealing no unstable condition in temperature. The connection of the thermistor probe of the actual device and the thermistor code provided by the customer was removed little by little. No variation occurred in the temperature values. When the terminal was completely removed, the determination of temperature ceased. The thermistor probe of the actual device was connected to the thermistor code provided by the customer again. The thermistor code was subjected bending force. No variation occurred in the temperature values. A review of the pump record noted some up-and-down movements in the arterial and venous temperatures, indicating that the temperatures were unstable. There was no correlation between the temperature and the blood flow rate. Based on the information in the pump record, saline solution @ approximately 24 oc was circulated in the blood phase for three hours. Subsequently, the temperature of the saline solution was elevated up to 37oc and the circulation was continued for another 3 hours. During the circulation, the temperature was monitored with a capiox centrifugal pump controller sp-200(neo). During this test no unstable condition in temperature was observed. A review of the device history record and shipping inspection record of the involved product code/lot number combination revealed there were no indication of production related anomalies. There is no evidence that this event was related to a device defect or malfunction. During the investigation, the reported unstable values in the temperature were not duplicated. (b)(4).
 
Event Description
The user facility reported while using the capiox device during priming and bypass, the temperature of the arterial blood was unstable. The procedure outcome and patient impact was reported to be unknown. A cardiovascular system s5 (livanova) was used.
 
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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 Key7391731
MDR Text Key104536670
Report Number9681834-2018-00036
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 04/03/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/03/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2020
Device Catalogue NumberCX-FX25RW
Device Lot Number171227
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/12/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/08/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/27/2017
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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