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

Catalog Number CX-XRX02302

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 11/08/2016

Event Type  malfunction  

Manufacturer Narrative

The actual device was returned to the manufacturing facility for evaluation.The actual sample was filled with saline solution and pressurized.A leak was noted at the purge port.Visual inspection of the purge port found that the purge line tube had a partial break at the edge of the purge port.Electron microscopic inspection of the cross-sections of the broken tube revealed that the surface was in the smooth state with the generation of streaks going inward the lumen.Simulation testing was conducted on a factory retained oxygenator sample.The purge line tube was exposed to a shock force.The sampling line tube became fractured at the joint.Electron microscopic inspection of the fracture cross-section found that the state of the surface was similar to that of the actual sample.The tube became partially broken.Subsequently, the cross-section of the broken tube was electron microscopically inspected.The surface was found to be in the smooth state with the generation of some streaks going in the direction the shock force had been applied to the tube.This state was found to be similar to that of the actual sample.A review of the device history record and the product release decision control sheet of the involved product code/lot# combination was conducted with no relevant findings.A search of the complaint file found no other report with the involved product code/lot# combination.There is no evidence that this event was related to a device defect or malfunction.Although the exact cause cannot be definitively determined based on the investigation results, it is likely the actual sample was subjected to a shock force.The device labeling does address the potential for such an event in the instructions-for-use (ifu): "warning do not use an oxygenator that leaks." all available information has been placed on file in quality assurance for appropriate tracking, trending and follow-up.

Event Description

The user facility reported leakage on the capiox device.Follow up communication with the user facility confirmed the following information: during the set-up and at the early stage of the priming procedure, the actual sample did not have any leak; it was reported that soon the customer noticed that the surface of the oxygenator was wet; when the customer slid the purge line tube slightly, the solution spouted out at the joint of the purge line tube to the purge port; and there was no patient involvement.

• Brand Name: CAPIOX FX OXYGENATOR
• Type of Device: OXYGENATOR
• 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: jennifer suh ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 6154176
• MDR Text Key: 61725798
• Report Number: 9681834-2016-00283
• 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: 12/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Catalogue Number: CX-XRX02302
• Device Lot Number: 160708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2016
• 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