MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX05; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number CX*FX05RE

Device Problem Gas/Air Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/26/2020

Event Type  Injury  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Pma/ 510(k): k130280.The actual sample was received for evaluation.Visual inspection revealed no obvious anomaly, such as a break, in the appearance.The actual sample after rinsed was built into a circuit with tubes and circulated with bovine blood (37°c 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 circulation at each flow rate, an air of 10ml was sent into the circulation over 30 seconds.As a result, no air came out of the oxygenator through the filter (an arterial filter was connected into the blood outlet port line and air was sent into the oxygenator module from the blood inlet port, while the circuit was closely observed for any air bubbles going in the oxygenator module and to the arterial filter).The tube that had connected the blood outlet port of the reservoir and the blood inlet port of the oxygenator was removed from the actual sample, closed one end, submerged in water, and then air pressure of 1000mmhg was applied from another end.As a result, no air leak was observed.A review of the device history record and product release decision control sheet of the involved product code/ lot number combination revealed no findings.Ifu states: ensure that the de-airing process is complete prior to initiating bypass.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.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 5l/min.Excessive gas flow rate will bring about pressure increase in the gas phase, allowing gaseous emboli to enter the blood phase.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.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 air entered the oxygenator module due to some factor(s) or that air was not completely removed from the device after the priming.However, 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 capiox device was used during the procedure and there was a problem associated with the unintended escape of a gas from the container in which it is housed.On bypass two air bubbles went up the arterial line, which activated the bubble sensor and removed via the cannula.They called a second perfusionist and they decided to ween the patient from bypass and circulate through the circuit.No air bubbles could be seen; however, they switched out the oxygenator.After the case was successfully completed, they reintroduced initial oxygenator to try and re -enact bubbles however, nothing was found.There was potential harm due to interruption of procedure and usage stop of oxygenator.There was no actual harm caused to the patient.

• Brand Name: CAPIOX FX05
• 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; 265 davidson ave suite 320; somerset, nj ; 2837866718
• MDR Report Key: 10008763
• MDR Text Key: 196762030
• Report Number: 9681834-2020-00065
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350781758
• UDI-Public: 04987350781758
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 04/29/2020

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: 06/30/2022
• Device Catalogue Number: CX*FX05RE
• Device Lot Number: 190729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2020
• Initial Date FDA Received: 04/29/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2019
• 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
• Patient Outcome(s): Other; Required Intervention