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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-FX15RE40
Device Problem Device Operational Issue (2914)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/20/2017
Event Type  malfunction  
Manufacturer Narrative
Patient identifier - requested but not provided. Age and 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 number for this product code is not required. The actual device was returned for evaluation. Visual inspection of the thermistor probe revealed no defects. The actual device was rinsed and dried. The temperature sensor cable which was provided by the involved customer was connected to the thermistor probe of the actual device. Then saline solution, with the initial temperature set to 8 degrees celsius, was circulated in the blood phase. While the saline solution was being warmed up in the constant-temperature bath of which temperature was set to 38 degrees celsius and the temperature of the saline solution was increasing, the temperature of the saline solution was determined with the actual thermistor probe and at the same time with a factory-retained thermistor probe for comparison. The temperatures obtained from the two thermistor probes were confirmed to be equivalent to each other. During this circulation, the reported indication of the single digits in the temperature was not duplicated. After the above test, saline solution at approximately 38 degrees celsius was circulated for another 1 hour and then its temperature was determined while it was stable with the actual thermistor probe and at the same time with a factory-retained thermistor probe for comparison. The temperatures obtained from the two thermistor probes were confirmed to be equivalent to each other. During this circulation, the reported indication of the single digits in the temperature was not duplicated. After the above test, the terminal of the temperature sensor cable connected to the thermistor probe of the actual device was removed little by little. No variation occurred in the temperature values. Consequently, the terminal was completely removed, then the determination of temperature ceased. During this test the reported indication of the single digits in the temperature was not duplicated. A review of the device history record and product release decision control sheet of the involved product code/lot number combination revealed no findings. A search of the complaint file found no previous report of this nature with the involved product code/lot number combination. During the investigation, the reported indication of the single digits in the temperature was never duplicated. The actual sample, after having been rinsed and dried, was the normal product. There is no evidence that this event was related to a device defect or malfunction. 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 thermistor probe on the capiox device was found to be defective. Follow up communication with the user facility confirmed the following information: the values of the determined arterial temperature were extremely unstable. It was reported that sometimes it went down to the single digits. There was no harm to the patient. The 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 Key7120406
MDR Text Key95081944
Report Number9681834-2017-00247
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 12/15/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/15/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2020
Device Catalogue NumberCX-FX15RE40
Device Lot Number170801
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/23/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/21/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2017
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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