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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-XRX25901
Device Problem Device Operational Issue (2914)
Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597)
Event Date 01/20/2018
Event Type  Injury  
Manufacturer Narrative
Udi - not required for this product code/ lot number combination. Implanted date: device was not implanted. Explanted date: device was not explanted. Pma/510(k): k130520. The actual device was returned for evaluation. Visual inspection upon receipt revealed no defects. The actual sample, after having been washed and dried, was tested for its gas transfer performance by being circulated with bovine blood at the flow rate of 6 and 4l/min. , fio2
=
100% and v/q
=
1. The obtained values were verified to meet manufacturer specifications as follows. [o2 transfer] @the flow rate of 6l/min. :384ml/min. @4l/min. :278ml/min. [co2 removal] @the flow rate of 6l/min. :336ml/min. @4l/min. :232ml/min. The pump record from the involved procedure was reviewed and the findings below were obtained. There were increases in paco2 @20:00 and @21:36 (this is the time immediately before the change-out of the actual sample) and at the time of these increases, the gas flow rate was increased to approximately 10l/min. As the result of the increase in the gas flow rate, paco2 was noted to have decreased @20:36 when the following blood gas measurement was conducted after the measurement @20:00. The state of paco2 after 21:36 is unknown since the blood gas data during the change-out of the actual sample is not available. There was no decrease in pao2 @20:00 and 21:36 when paco2 increased. Functional testing was conducted on the actual device. A) in order to reproduce the state of the venous blood before the oxygenator at the time the increase in paco2 was noted during the involved procedure, the venous blood sample was adjusted by referring to the circulation conditions and the gas data @21:36 (the time immediately before the change-out of the actual sample) so that paco2 after the oxygenator would result in 52. 7mmhg. It was found that it was when pvco2 before the oxygenator was 71. 1mmhg that paco2 after the oxygenator turned to be 54. 2mmhg. B) in order to reproduce the state of the venous blood before the oxygenator before paco2 increased during the involved procedure, the venous blood sample was adjusted by referring to the circulation conditions and the gas data @21:06 so that paco2 after the oxygenator would result in 37. 4mmhg. It was found that it was when pvco2 before the oxygenator was 44. 5mmhg that paco2 after the oxygenator turned to be 37. 5mmhg. Based on the results from above tests, it is likely that pvco2 increased in the period of time from 21:06 to 21:36. C) in order to see the effect of the blood temperature on the increase in paco2, the same test as the one conducted in a) but the temperature of the arterial blood being set to 37. 0 degrees c instead of 20oc. Paco2 turned to be 42. 2mmhg. 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 other report with the involved product code/lot# combination. The ifu states: measure blood gases and make necessary adjustments as follows. Control paco2 by changing the total flow rate. To decrease paco2, increase total gas flow. To increase paco2, decrease total gas flow. The investigation above verified that the actual sample after having been rinsed and dried was the normal product, with its gas transfer performance meeting manufacturer specifications. There is no evidence that this event was related to a device defect or malfunction. Although the exact cause cannot be determined based on the available information, from the investigation result, it is likely there was an increase in pvco2 in the period of time from 21:06 to 21:36, which caused paco2 to increase. As a cause of the increase in pvco2, it is likely that the initiation of the blood circulation at the full flow rate at the termination of the selective cerebral perfusion allowed the blood containing increased pvco2 to flow into the actual sample. The conditions, including the increased blood flow rate, a low blood temperature and others, led paco2 to increase easily. (b)(4).
 
Event Description
The user facility reported an insufficient gas-exchange on the capiox device. It was reported that at the stage of rewarming, the performance of co2 removal was deteriorated with co2: a 52. 7mmhg at the gas flow rate of 10l/min. It became out of control with the adjustment of the gas flow rate. As it was before the rewarming, the actual sample was changed out and the procedure was completed. The actual device was changed out. The amount of blood loss is unknown. The patient was not harmed. It was reported that the procedure was completed successfully.
 
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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 Key7278597
MDR Text Key100391119
Report Number9681834-2018-00010
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 02/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2019
Device Catalogue NumberCX-XRX25901
Device Lot Number170928
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/26/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/22/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/28/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/16/2018 Patient Sequence Number: 1
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