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

Catalog Number CX-XRY32302

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/28/2018

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.510(k): k130520.The actual device was returned for evaluation.Visual inspection revealed no anomalies, such as a break, in the appearance.Saline solution was let to flow through the actual device by gravity.Another unaided visual inspection of the actual device revealed no clot formation.The actual device was fixed with saline solution containing glutaraldehyde solution.Subsequent visual inspection, after the housing component had been removed, did not reveal any clots on the outer surface of the filter.The filter was removed from the oxygenator module for further visual inspection.No formation of clots was revealed on the outer or inner surface.Unaided visual inspection of the oxygenator module did not reveal any formation of clots.The fiber winding was confirmed to be in the normal state.The fiber layer was removed from the winding in increments of 2mm and each layer was subjected to visual inspection.There was no clot formation that was visible with the naked eye on the fiber.The fiber and the outer cylinder were removed from the heat exchanger module and the inside of the heat exchanger module was subjected to visual and magnifying inspections.No formation of clots was revealed.The filter was removed from the oxygenator module in above test and was inspected under magnification.No formation of clots was revealed.The fiber layers removed during the test in above no.6 were inspected under magnification.No formation of clots was observed.The filter removed from the oxygenator module in above no.4 was inspected under electron microscope.The adhesion of a slight amount of erythrocyte components was revealed.Electron microscopic inspection of the fiber on each layer on the upper side of the fiber winding obtained in the above test revealed the adhesion of a slight amount of erythrocyte components, including red blood cells, white blood cells and platelets, on the fiber.A review of the device history record of the involved product code/lot number combination revealed no findings.A search of the complaint file found no previous report of this nature with the involved product /lot# combination.There is no evidence that this event was related to a device defect or malfunction.During the inspection of the actual device, the adhesion of a slight amount of erythrocyte components was revealed.However, it cannot be determined if this had any cause-and -effect relationship with the reported deterioration of the gas transfer performance.(b)(4).

Event Description

The user facility reported that the actual sample was used on the patient with the body surface area ,1.8m squared in a total arch replacement.After de-clamping, o2 addition quickly started to fail to catch up with the required volume.With fio2=100%, pao2 went to 80mmhg.Gas flow rate=5l/min., and the blood flow rate=4.8l/min., also with no anomaly in act or in the pressure inside the circuit, pao2 went down to 80mmhg.The patient was weaned from the pump safely.The actual sample was not changed out.There was no blood loss.There was no harm to the patient.

• 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: mark vornheder ; reg. no. 2243441; 950 elkton blvd; elkton, MD 21921 ; 8002837866
• MDR Report Key: 7884804
• MDR Text Key: 120740123
• Report Number: 9681834-2018-00158
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 09/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: CX-XRY32302
• Device Lot Number: 180329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/30/2018
• Initial Date FDA Received: 09/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2018
• 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