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

Catalog Number ZZ*FX15RW30

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

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 the purge line tube had been almost fractured off at the joint at the port on the oxygenator.There was no other anomalies on the remainder of the device.The actual device was rinsed, saline solution was flowed into the oxygenator module and the purge done by gravity drop.A leak was found around the joint between the purge line and the oxygenator module.Magnifying and electron microscopic inspections of the fracture cross-section of the purge line tube on the port side confirmed there was no embedded foreign particle or entrainment of air bubbles which would have contributed to the generation of the fracture.It was revealed some segments were in the smooth state and other segments in the rough state with the generation of some streaks on the smooth segment.Simulation testing was conducted.The state of the fracture on the actual device 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 purge 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 of 4°c for 12 hours.The purge 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.The production lot number was not provided by the user facility which prevented a meaningful review of production and complaint records.There is no evidence this event was related to a device defect or malfunction.The investigation results verified the actual device did not have any inherent deficiencies which could have contributed to the fracture of the purge line tube.While the exact cause of the reported event cannot be definitively determined based on the available information, it is likely the actual device was subjected to a shock force which exceeded the strength limit of this product in the state of being cooled by having been left under a low temperature during transportation, resulting in the fracture of the tube.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 an oxygenator that leaks.(b)(4).

Event Description

The user facility reported leakage in the capiox device.Follow up communication with the user facility confirmed the following information: during priming on a large child oxygenator the oxygenator was noted to have a significant leak where the glued purge line enters the oxygenator at the outlet port; and there was not 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: terry callahan ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 6954711
• MDR Text Key: 90535603
• Report Number: 9681834-2017-00223
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZZ*FX15RW30
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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