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

Catalog Number CX-FX05RE

Device Problem Device Difficult to Setup or Prepare (1487)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/21/2020

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 break or any other anomaly that could cause air to enter the oxygenator or reservoir.In the oxygenation module, there was no formation of blood clot that could lead to an obstruction.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).Subsequently, pressure drop was determined while bovine blood (@37°c and hct35%) was circulated at 1.5l/min in the above test set.The test result met the manufacturer specifications and no obstruction was observed.A review of the device history record and product release judgement record of the involved product code/lot number combination revealed no findings.Ifu states: 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.Do not obstruct gas outlet port.Pressure in the blood phase should always be higher than that in the gas phase.The gas flow rate should not exceed 5l/min.Excessive gas flow rate will bring about pressure increase in the gas 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.Total flow rate of the arterial line and any separate arterial lines must not exceed the flow rate at the oxygenator inlet port.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).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 involved capiox device was used during a pediatric ecc procedure; they observed that air was entering an oxygenator.The oxygenator was changed out immediately.They believe that air was drawn into the oxygenator due to negative pressure generated in muf pump, and commented that, as a cause of the negative pressure, a kink might have occurred in the blood-outlet side tube or blood clots might have clogged the blood-inlet port.Act greater than or equal to 600 sec.There was no problem was found in the pressure level before and after the oxygenator.The procedure outcome was successful.The patient was not harmed.

• 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: 10166619
• MDR Text Key: 195529549
• Report Number: 9681834-2020-00096
• 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: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: CX-FX05RE
• Device Lot Number: 191210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2019
• 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