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

Catalog Number CX-XRX52203

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 03/26/2018

Event Type  malfunction  

Manufacturer Narrative

Patient identifier - requested but not provided.Age & date of birth - requested but not provided.Sex - requested but not provided.Weight - requested but not provided.Ethnicity - requested but not provided.Race - requested but not provided.Udi - not required for the reported product code.Implanted date: device was not implanted.Explanted date: device was not explanted.The 510(k-) k130520.The actual device was returned for evaluation.Visual inspection revealed no anomalies.With the tubes connected to the actual device upon receipt kept as they were, priming was carried out by saline solution to run through the actual device.The actual device was primed in the normal manner with no occurrence of entrance of air into the device or of a leak at a tube joint.The actual device was filled with saline solution and pressurized with air at 2.0kgf/cm2.No leak was confirmed.While the actual device was being circulated at the minimum flow rate of 0.5l/min, air was sent inside the oxygenator module from the gas in-port at the maximum flow rate of 20l/min.There was no air coming out through the filter.The actual device was filled with saline solution.With the blood-out side and blood-in side being clamped, air was sent into the oxygenator module from the gas-in port and the pressure drop was determined.It was found to be equivalent to that of the factory-retained sample.The actual device was built into a circuit with tubes, and the pressure drop was determined at each flow rate and verified to meet the specifications.In order to check the presence of air, a bubble trap was added to the blood-out side in the circuit.Air was sent into the oxygenator module from the blood-in side gradually.At any of the flow rates, no air came out through the filter and no air was trapped in the babble trap.A review of the device history record from the reported product code/lot number combination was conducted with no findings.There is no evidence that this event was related to a device defect or malfunction.During the investigation the actual device did not pose any anomalies which would relate to the reported air entrainment into the device.(b)(4).

Event Description

The user facility reported in the case of selective cerebral perfusion, after the initiation of the extracorporeal circulation, while the cerebral perfusion was being proceeded, air was noted to have been pulled into the circuit.The procedure outcome and patient condition was reported to be unknown.

• 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: 7444011
• MDR Text Key: 106625482
• Report Number: 9681834-2018-00053
• 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: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: CX-XRX52203
• Device Lot Number: 171212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2017
• 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