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

(b)(6).Implanted date: device was not implanted.Explanted date: device was not explanted.510(k): k130280.The actual device was received for evaluation.Visual inspection revealed no anomalies.The actual device, after having been rinsed and dried, was tested for its gas transfer performance as follows; bovine blood arranged to hb12.0 g/dl, temp.37oc was circulated in the oxygenator module under the following conditions: v/q=1, fio2=100% and the flow rate =@ 1l/min.And 2l/min.Result: o2 transfer: @2l/min.= 120ml/min.@1l/min.= 67ml/min.Co2 removal: @2l/min.= 96ml/min.@1l/min.= 58ml/min.No anomalies were revealed in the gas transfer performance of the sample, with the obtained values meeting the manufacturer specifications.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 second oxygenator, 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%.A review of the device history record of the involved product code/lot number combination revealed no findings.Ifu states: start gas supply with v/o=1, fio2=100%, then make adjustments based on blood gas measurements.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 the initiation of the circulation with the actual device with fio2 set to 60% led the volume of o2 supply to become insufficient for the patient's metabolism, resulting in the decrease in svo2 then in pao2.However, the exact cause of the reported event cannot be definitively determined based on the available information.This report is for the first device used, for the second device reported that was used on the same patient, see mdr 9681834-2019-00020.(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: 8349572
• MDR Text Key: 136494535
• Report Number: 9681834-2019-00019
• 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
• Treatment: SENKO-MADE TUBING PACK
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 2 YR
• Patient Weight: 11