MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number 1CX*FX05RW

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/10/2019

Event Type  Injury  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.A review of the device history record and product release decision control sheet of the involved product code/lot# combination was conducted with no findings.(b)(4).

Event Description

The user facility reported that the capiox oxygenator failed to provide adequate oxygenation during the cardiopulmonary bypass run.The event did not cause a delay with the procedure.The device was changed out for a new unit.A second oxygenator was added to the bypass circuit to compensate for the failed unit.The surgery was completed successfully.There was no blood loss.There was no injury to the patient.

Manufacturer Narrative

The actual sample was returned for evaluation.Visual inspection revealed that there was no obvious anomaly that could lead to the poor gas transfer such as a break or deformity in the appearance.The actual sample, after having been rinsed and dried, was tested for its gas transfer performance in accordance with the factory's shipping inspection protocol.Bovine blood arranged to (hb12.0 g/dl, temp.37°c., ph: 7.4, svo2: 65% and pvco2: 45mmhg) circulated in the oxygenator module under the following conditions: @ v/q=1, fio2=100% and the flow rate of 2l/min.And 1l/min.The results: o2 transfer: @2l/min.= 117ml/min.@1l/min.= 66ml/min; co2 removal: @2l/min.= 97ml/min.@1l/min.= 57ml/min.No anomalies were revealed in the gas transfer performance of the actual sample, with the obtained values meeting manufacturer specifications.Ifu states: capiox fx05 is designed to operate at blood flow rates within the range of 0.1 to 1.5 l/min.Do not use any blood flow rate outside this range.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.Start gas supply with v/q=1 and fio2=100%, then make adjustments based on blood gas measurements.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.The investigation results verified the returned sample was of the normal product.It is likely that the oxygen supplied under the circulation conditions (e.G., flow rate, fio2, etc.) during the procedure was insufficient compared to the patient's oxygen consumption; when the patient's metabolism was activated by the rewarming, the oxygen supply became insufficient compared to the patient's oxygen consumption; or water drops were generated due to a wet lung phenomenon, the gas transfer was obstructed consequently.However, the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 9271393
• MDR Text Key: 164817784
• Report Number: 9681834-2019-00192
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350781772
• UDI-Public: 04987350781772
• Combination Product (y/n): N
• PMA/PMN Number: K071572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: 1CX*FX05RW
• Device Catalogue Number: CX*FX05RW
• Device Lot Number: 190508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2019
• Date Manufacturer Received: 11/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other