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

Model Number 1CX*FX05RW

Device Problem Device Difficult to Setup or Prepare (1487)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/11/2019

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.(b)(6).The actual device was not returned to the manufacturing facility for evaluation.Therefore, the investigation was based on user facility information and evaluation of the retention sample.The retention sample was evaluated; visual inspection revealed no anomalies.The sample was built into a circuit with tubes and primed with saline solution in accordance with the ifu for this product.There was no air remaining inside the sample.The sample was circulated with bovine blood (@37oc and hb12g/dl) at the back pressure of 200mmhg and at each blood flow rate of 0.5l/min., 1.0l/min., and 1.5l/min.During the circulation at each flow rate, an air of 10ml was sent into the circulation in 30 seconds from the blood inlet port.No air came through the filter out of the oxygenator module.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.Ifu states: minimum operating volume in the reservoir is 15ml volume below 15ml will pull air from the reservoir.Set appropriate blood storage level, relative to venous flow rate, to prevent gaseous emboli passing to patient.When capiox fx05 oxygenator module is used separately from the hardshell reservoir, set the module so that the upper end of the fibers is lower than the blood level in the venous reservoir.This prevents gaseous emboli from entering the blood phase from the gas phase.Do not obstruct gas outlet port.Avoid buildup of excess pressure in the gas phase to prevent gaseous emboli entering the blood phase.Pressure in the blood phase should always be higher than that in the gas phase (to prevent gaseous emboli entering the blood phase.) the gas flow rate should not exceed 5 l/min.Excessive gas flow rate will bring about pressure increase in the gas phase, allowing gaseous emboli to enter the blood phase.During recirculation, do not use pulsatile flow and do not stop the blood pump suddenly as these actions may cause gaseous emboli to enter the blood phase from the gas phase due to inertia force.To prevent gaseous emboli from entering the blood phase, make sure that the arterial pump flow rate always exceeds the flow rate of the cardioplegia line.The blood flow rate of the cardioplegia line should not exceed 0.5l/min.The blood flow into the cardiotomy filter should not exceed the rate of 1.5l/min.The investigation results verified the retention sample was of the normal product.However, without the return of the actual sample, the exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).

Event Description

The user facility reported that the involved capiox device pushed air into the aorta during cardiopulmonary bypass.There was approximately 10 to 15-minute delay; however, they did not change the product out.They still used the device until the end of the surgery.The event did not cause injury, and the procedure was completed successfully.There was no blood loss.When they increased the venous reservoir level and decreased the vent suction, the amount of air seen decreased significantly.

• 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
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: theresa mussaw ; reg. no. 2243441; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 8884373
• MDR Text Key: 160047734
• Report Number: 9681834-2019-00150
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350781772
• UDI-Public: 04987350781772
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/07/2022
• Device Model Number: 1CX*FX05RW
• Device Catalogue Number: CX*FX05RW
• Device Lot Number: 190207
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2019
• 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