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

Catalog Number ZZ*FX05RE

Device Problem Device Difficult to Setup or Prepare (1487)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2019

Event Type  Injury  

Manufacturer Narrative

Weight - (b)(6) kgs.Udi - n/a as this product is released from ashitaka factory as a bulk unit.Implanted date: device was not implanted.Explanted date: device was not explanted.Pma/510(k) number- k130280.The actual device has been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.Review of device history records and the product decision control sheet of the involved product/lot# combination was conducted with no relevant findings.(b)(4).

Event Description

The user facility reported that an un-expected aeration of the capiox oxygenator during cpb.The ec terumo fx05 circuit was primed in a standard way.All bypasses were closed, and the pump occlusion was adjusted.The whole ec system was prepared, and fluid circulated through main tube.Next, the pump was stopped, and they clip clamped the main tube.Massive aeration of blood side of the oxygenator occurred immediately.The device was replaced with a cx-cz107x, lot 1903238.The patient was treated by standard way after problem elimination (change ec circuit).This incident had no impact on the patient.The patient did not lose any blood.Perfusion protocol is available.The procedure was delayed for approximately 20 minutes.The procedure was finished with a complete exchange of tubing set with oxygenator.There are no known patient consequences or harm to the patient.The procedure was completed successfully.There were no other devices or equipment being used with the reported product.

Manufacturer Narrative

This report is being submitted as follow up no.1 to update section h3, and to provide the completed investigation results.The actual sample was returned for product evaluation.Visual inspection upon receipt did not find any obvious anomaly, such as a break, in the appearance.The sample was built into a circuit with tubes and primed with saline solution in accordance with the ifu for this product.Any leak that could have caused air to remain or enter in the sample was not observed.The actual sample 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.No air came out 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 out of the oxygenator module toward the arterial filter.Ifu states: ensure that the de-airing process is complete prior to initiating bypass (d.Initiation of bypass, warning).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.(f.Termination of bypass, warning).Do not obstruct gas outlet port.Avoid build-up of excess pressure in the gas phase to prevent gaseous emboli entering the blood phase.(warnings).Pressure in the blood phase should always be higher than that in the gas phase to prevent gaseous emboli entering the blood phase.(warnings).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.(warnings).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 0.5 l/min.(warnings) the investigation result verified that the actual sample was the normal product without any leak that could have caused air to enter the oxygenator module, having the normal air removal performance.It is assumable, as a cause of this complaint, that air entered the oxygenator module due to some factor(s) or that air was not completely removed from the device during the priming.Since the actual sample was verified to be the normal product, the cause of this complaint cannot be determined definitely from the available information.Terumo medical products (tmp) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.

• Brand Name: CAPIOX FX OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 9528923
• MDR Text Key: 189074145
• Report Number: 9681834-2019-00223
• Device Sequence Number: 1
• Product Code: DTZ
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: ZZ*FX05RE
• Device Lot Number: 181109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Date Manufacturer Received: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 6 MO
• Patient Weight: 5