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

Catalog Number CX-FX25RW

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/15/2017

Event Type  Injury  

Manufacturer Narrative

This is the product code that is not required to be registered with fda.The actual device has been returned to the manufacturing facility for evaluation.Visual inspection of the actual device upon receipt found that the gas in side and the gas out side had been discolored into pink with a fluid pink in color gathered in the gas in side.The fluid gathered in the gas in side was collected and centrifugalized.As the result, no deposition occurred in it.This indicated that this fluid did not contain the blood cell components.The actual device was rinsed and filled with saline solution.With the blood outlet port clamped, an air of 2.0kg/cm2 was applied to the inside of the device from the blood inlet port.No leak was confirmed.The actual device, after having been dried, was tested for its gas transfer performance.Bovine blood was circulated in the oxygenator module under the following conditions: @ v/q=1, fio2=100% and the flaw rate of 6l/min.And 4l/min.Result: o2 transfer: @6l/min.= 403ml/min.@4l/min.= 283ml/min.Co2 removal: @6l/min.= 342ml/min.@4l/min.= 237ml/min.No anomalies were revealed in the gas transfer performance of the actual sample, with the obtained values meeting manufacturer specifications.A review of the device history record and product release decision control sheet of the involved product code/lot number combination revealed no relevant findings.A search of the complaint file found no previous report of this nature with the involved product code/lot number combination.There is no evidence this event was related to a device defect or malfunction.The above investigation verified that the actual device was the normal product without any defectives which could have led to a leak or the insufficient gas transfer performance.While the exact cause of the reported event cannot be definitively determined based on the available information, based on the findings that the fluid gathered inside the gas in side did not contain the blood cell components and that the actual device did not have any leak, it is likely that a plasma leak occurred during the actual use.The device labeling does address the potential for such an event in the instructions-for-use (ifu) with statements such as the following: do not use this product for the period in excess of six hours.Excessive use for over six hours may lead to plasma leak and thrombi formation, which may compromise the gas exchange performance.(b)(4).

Event Description

The user facility reported leakage on the capiox device.Follow up communication with the user facility confirmed the following information: during an urgent arch replacement due to artery dissection, seven hours after starting the circulation, the physician found a fluid pink in color dropping at the lower part of the gas-out side.The actual device was changed out.No known impact 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: 7029805
• MDR Text Key: 92040979
• Report Number: 9681834-2017-00236
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: MY
• 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: 11/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: CX-FX25RW
• Device Lot Number: 170601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2017
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/15/2017
• Initial Date FDA Received: 11/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2017
• 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 Age: 59 YR
• Patient Weight: 70