MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

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.

• Brand Name: CAPIOX FX OXYGENATOR
• Type of Device: OXYGENATOR, 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 Key: 7278597
• MDR Text Key: 100391119
• Report Number: 9681834-2018-00010
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• 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 Received: 02/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: CX-XRX25901
• Device Lot Number: 170928
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 97