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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-XRX61301
Device Problem Unable to Obtain Readings (1516)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/24/2019
Event Type  malfunction  
Manufacturer Narrative
Patient identifier - requested, not provided. Age & date of birth - requested, not provided. Patient sex - requested, not provided. Weight - requested, not provided. Ethnicity - requested, not provided. Race - requested, not provided. Udi - not required for product code. Implanted date: device was not implanted. Explanted date: device was not explanted. 510k - k130520. (b)(4). The actual device was received for evaluation. A movie was provided and reviewed and revealed that the blood temperature monitor connected to the luer thermistor showed a measurement failure code, or a temperature that differed from the patient's body temperature (34 degree celsius). The luer thermistors upon receipt were inspected under a magnifier and found to have no anomaly including a break in the appearance. Visual and magnifying inspection of the blue thermistor probe cable (blue cable) and red thermistor probe cable (red cable) did not find any anomaly including a break in the appearance. The actual sample after being rinsed was built in a test circuit. Physiological saline solution was circulated in the blood channel at a flow rate of 5l/min and the temperature was measured every 30 seconds using various combinations of luer thermistors and the cables as follows. The measurement results showed no difference in measured value between those of the actual samples (luer thermistor and cables) and that of a factory-retained luer thermistor sample. The reported instability in reading temperatures was not reproduced. The responsiveness of the luer thermistors were tested by the following test method. While physiological saline solution of 20 degree celsius as the initial temperature was being circulated, warm water of 34 degree celsius from a constant temperature water bath was fed into a heat exchanger, then the responsiveness of the samples was evaluated. The test results showed no difference in responsiveness between the actual samples and the factory-retained sample. The reported instability in reading temperature was not reproduced during this test. While the connection between the actual luer thermistor samples and the actual cables was intentionally loosened gradually, the read temperatures were recorded. No variation in read temperature was observed. Temperature could not be read when they were disconnected completely. The reported instability in reading temperature was not reproduced during this test. After the actual luer thermistors and the actual cables were re-connected, the sensor cable was bent gradually while the read temperatures were recorded. The reported instability in reading temperature was not reproduced during this test. A review of the device history record and product release decision control sheet of the product code/lot# combination was conducted with no findings. Based on the provided information and investigation results, there is no definitive 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. Terumo medical products (tmp) (importer) registration no. 2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no. 9681834.
 
Event Description
The user facility reported that the involved capiox custom pack was used during the procedure. There were problems in reading the arterial/venous blood temperatures. The temperature deviated from the actual temperature that was shown on the display; there was no data shown on the display. The same problems occurred after exchanging the thermistor probe cables. The patient was not harmed. The procedure outcome was not reported.
 
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Brand NameCAPIOX FX OXYGENATOR
Type of DeviceOXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
TERUMO CORPORATION, ASHITAKA
150 maimaigi-cho
fujinomiya city, 418
JA 418
Manufacturer (Section G)
TERUMO CORPORATION, ASHITAKA
reg. no. 9681834
150 maimaigi-cho
fujinomiya city, 418
JA 418
Manufacturer Contact
theresa mussaw
reg. no. 2243441
2101 cottontail ln.
somerset, NJ 08873
8002837866
MDR Report Key9329083
MDR Text Key220772563
Report Number9681834-2019-00195
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 Other Health Care Professional
Type of Report Initial
Report Date 11/15/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/15/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2020
Device Catalogue NumberCX-XRX61301
Device Lot Number190618
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/29/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/24/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/18/2019
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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