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

Catalog Number CX-XRX23603

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/02/2017

Event Type  malfunction  

Manufacturer Narrative

Udi number is not required for this product code.The actual device has been returned to the manufacturing facility for evaluation.Visual inspection found no anomalies in the visual appearance.The actual device, after having been rinsed and dried, was filled with approximately 1000 mmhg of saline solution and pressurized at approximately 1000 mmhg.No leak was confirmed.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 reported product code/lot number combination.There is no evidence this event was related to a device defect or malfunction.While the exact cause of the reported event cannot be definitively determined based on the available information, it is likely the purge line was pinched and cut with a cutting tool resulting in the reported event.The device labeling does address the potential for such an event in the instructions-for-use (ifu) with statements such as the following: warning: to prevent gaseous emboli from entering the blood phase, make sure that the arterial pump flow rate always exceeds the flow rate of the cardioplegia line.The blood flow rate of the cardioplegia line should not exceed 1 l/min.Cautions: recirculate the priming solution at a rate of 4 l/min or higher to facilitate air removal.Failure to remove air from the oxygenator may result in serious injury to the patient.(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 a leak in the capiox device during a mics-mvp case.Follow up communication with the user facility confirmed the following information: around two and half hours after the initiation of the extracorporeal circulation the user was about to send cardioplegia; the air sensor connected to the out port of the oxygenator went off; there was no air visible with the naked eye; no anomalies noted on the display of the bubble sensor monitor on the heart-lung machine; the extracorporeal circulation was continued and completed successfully; and the patient was not harmed.

• 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: 6986884
• MDR Text Key: 91207275
• Report Number: 9681834-2017-00227
• 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: 10/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: CX-XRX23603
• Device Lot Number: 170809
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2017
• 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