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

Catalog Number CX-FX15W

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/05/2017

Event Type  malfunction  

Manufacturer Narrative

Udi number for this product code is not required.The actual device was returned to the manufacturing facility for evaluation.Visual inspection found no anomalies in the appearance.The actual device was subjected to another visual inspection after saline solution was let to flow through the device by gravity drop.Clots were found to have formed mainly on the bottom area.However, it cannot be determined if the clots were formed during actual use or on its way back to the factory.The actual device, after having been rinsed and dried, was tested for its gas transfer performance.Bovine blood arranged to hb12.0 g/dl, temp.37°c was circulated in the actual device under the following conditions: @ v/q=1, fio2=100% and the flaw rate of 5l/min.And 3l/min.Result: o2 transfer: @5l/min.= 330ml/min.@3l/min.=216ml/min.Co2 removal: @5l/min.= 264ml/min.@3l/min.= 171ml/min.No anomalies were revealed in the gas transfer performance of the actual device with the obtained values meeting factory specifications.A review of the perfusion record obtained the following findings.The patient's (b)(6).Paco2 was increased to 65.2 mmhg at 13:55.The gas flow rate was increased during 15:50-16:00 and a decrease in paco2 was noted at 16:42.Pao2 stayed around 369 - 483 mmhg.Pao2 was 441 mmhg at 13:55 when paco2 increased.The patient started to be cooled down at 12:40.The patient's temperature was 28.3° at 13:55 when paco2 started to increase.After 16:20 the patient's temperature increased gradually and paco2 started to decrease.A review of the device history record from the reported product code/lot number combination was conducted with no relevant findings.A search of the complaint file found no previous report of this nature with the involved product /lot number combination.There is no evidence this event was related to a device defect or malfunction.The investigation result verified the actual device was normal product meeting facility specifications.While the exact cause of the reported event cannot be definitively determined based on the available information, it is likely the increase in pvco2 noted at 13:55 affected paco2.As a cause of the increase in pvco2, the below factors can be inferred.The presence of co2 sweeping gas in the operative field led the blood containing high pco2 to be suctioned, resulting in the reported increase in pvco2.Lowered blood temperature made it difficult for co2 gas to be removed.The device labeling does address the potential for such an event in the instructions-for-use (ifu) with statements such as the following: control paco2 by changing the total gas flow.To decrease paco2, increase total gas flow.To increase paco2, decrease total gas flow.(b)(4).All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.

Event Description

The user facility reported insufficient gas exchange in the capiox device during a procedure.Follow up communication with the user facility confirmed the following information: during circulation the paco2 value increased to higher than 60 mm hg; the gas flow rate was increased to 8 l/min; afterward, the paco2 value decreased temporarily; it started to increase again; there was no problem in the pao2 value; it was reported the customer always uses co2 sweep gas in the operative field; the actual device was not changed out; and there was no harm to the patient.

• 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: 6913271
• MDR Text Key: 88242449
• Report Number: 9681834-2017-00207
• 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: 10/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: CX-FX15W
• Device Lot Number: 170329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2017
• 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 Weight: 51