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

Catalog Number CX-FX05RW

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem Blood Loss (2597)

Event Date 01/29/2019

Event Type  Injury  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Pma/510(k): k130280.The actual device was received for evaluation.Visual inspection revealed no anomalies.The actual device was flushed with saline solution by gravity drop.Subsequent visual inspection did not find any clots visible with the naked eye.The actual device was fixed with glutaraldehyde solution and the housing component and the filter were removed from the oxygenator module.Visual inspection of the filter removed from the oxygenator module found the formation of clots on the outer surface.Visual inspection of the oxygenator module, after the housing component and the filter having been removed from it, did not find any clots visible with the naked eye on it.There was no anomaly in the state of fiber winding.The fiber layers were removed from the winding in increments of 2 mm and each layer was subjected to visual inspection.Visual inspection of each fiber layer did not find any clots visible with the naked eye.The outer cylinder was removed and the heat exchanger module was subjected to visual and magnifying inspections.No presence of a clot formation was confirmed.Magnifying inspection of the both sides of the filter removed from the oxygenator module confirmed no presence of clot formation.Magnifying inspection of the fiber layers removed from the oxygenator module confirmed no presence of clot formation.Electron microscopic inspection of the outer and inner surfaces of the filter removed from the oxygenator module revealed the adhesion of blood corpuscle components, including red blood cells and deformed red blood cells (echinocytes), to them.Electron microscopic inspection of the upper segments of the fiber layers removed from the oxygenator module revealed the formation of fibrin nets on them and the adhesion of blood corpuscle components, including red blood cells, deformed red blood cells (echinocytes) and blood platelets, to them.The perfusion record from the involved procedure was reviewed and revealed the following: the values in pao2 and svo2 started to drop at the initiation of the circulation.At 12:06, pao2 started to increase with the increase in fio2 from 60% to 80% at the same time.After the increase in fio2, svo2 showed the tendency of increase.After the initiation of the circulation with the actual sample, pao2 stayed around 150mmhg, and started to increase after 12:23 when fio2 was increased from 80% to 90%.Following the gradual decrease in pao2 around 15:31, svo2 also started to decrease gradually.Around 15:42 when fio2 was increased gradually from 70%, svo2 stayed around 80%.Around 15:31 when svo2 started to decrease, the rate of rectal temperature rising started to increase.A review of the device history record of the involved product code/lot number combination revealed no findings.Ifu states: upon patient rewarming, adjust o2 concentration, gas flow rate and blood flow rate by increasing them as needed based on an increase in patient's metabolism.Failure to adjust the gas supply and the blood flow rate appropriately may cause insufficient o2 supply needed or the amount of the patient's gaseous metabolism.Measure blood gases and make necessary adjustments as follows.Control pao2 by changing concentration of oxygen in ventilating gas using gas blender.To decrease pao2, decrease fio2.To increase pao2, increase fio2.There is no evidence that this event was related to a device defect or malfunction.The investigation results verified the returned sample was of the normal product.Based on the investigation results, it is likely that rewarming of the patient activated his/her metabolism and the required o2 volume increased.This led svo2 to get decreased, resulting in the decrease in pao2.However, the exact cause of the reported event cannot be definitively determined based on the available information.This report is for the second device used, for the first device reported that was used on the same patient, see mdr 9681834-2019-00019.(b)(4).

Event Description

The user facility reported he circulation with the involved capiox started at 11:51 with fio2=60%.Due to po2 being 79mmhg, fio2 was increased to 80% at 12:06.Then po2 increased to the better level.As there was a possibility that the operation would be prolonged, the user decided to change out the actual sample to the second oxygenator.With the second oxygenator, they were not able to get the data they had expected.Doubting malfunction of the involved gas blender, they changed out the gas blender as well at 12:23.After that, they proceeded the operation with no gas transfer-related problem.At 15:46, when the clamp was released, the gas transfer performance was degraded.They completed the procedure with the second oxygenator and the patient was weaned off the bypass safely.The reported blood loss was 50ml.The procedure was completed successfully.The patient impact 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: mark vornheder ; reg. no. 2243441; 950 elkton blvd; elkton, MD 21921
• MDR Report Key: 8349571
• MDR Text Key: 136604184
• Report Number: 9681834-2019-00020
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071572
• 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: 02/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: CX-FX05RW
• Device Lot Number: 181009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2019
• Initial Date FDA Received: 02/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2018
• 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
• Patient Outcome(s): Other
• Patient Age: 2 YR
• Patient Weight: 11