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

Catalog Number ZZ*FX05RW

Device Problems Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The actual device was returned to the manufacturing facility for evaluation.Visual inspection upon receipt confirmed the customer's observation.The sampling line tube had been fractured at the joint of the oxygenator blood outlet port.The sampling line tube was cut out vertically into a piece for dimensional inspection.The inside and outside diameters were confirmed to meet manufacturing specification.Magnifying and electron microscopic inspection of the fracture cross-sections found some segments were in a smooth state and other segments in a rough state.Simulation testing was conducted.The state of the fracture on the actual sample is experientially known to be consistent with the state when the tube has been damaged as a result of exposition to a shock force under a cold temperature.The reproductive tests were conducted on the current product sample as follows.The sampling line tube of a current product sample was exposed to a shock force at the joint of the tube and the oxygenator outlet port after having been left under a low temperature for 12 hours.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 very similar to that of the actual sample.A review of the device history records and 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 one other report with the involved product code/lot# combination.See mdr 9681834-2017-00017 for details.There is no evidence that this event was related to a device defect or malfunction.Although the exact cause of the reported event cannot be definitively determined based on the available information, it is likely that the actual sample was subjected to a shock force after having been left at a low temperature, resulting in the reported breakage of the tube.The device labeling does address the potential for such an event in the instruction for use (ifu) with the statement such as the following: "do not use if the package or device is damaged (e.G.Cracked) or any of the part caps are off." (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 damage to the capiox device.Follow up communication reported the following information: the arterial sample line from the oxygenator out port has sheared off; when the device is received at the terumo uk facility the oxygenator is removed from its original bag and placed into a pre-connected tubing set; all packaging is validated; the tubing is attached when it leaves the uk plant, but arrived at the hospital damaged; there is nothing on top of the oxygenator during transit; and there was no patient involvement.

• 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: jennifer suh ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 6329845
• MDR Text Key: 67392701
• Report Number: 9681834-2017-00016
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K071572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: ZZ*FX05RW
• Device Lot Number: 160803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2016
• 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