MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX RX15 W/ 3L RESERVIOR (LT. PORT); OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number CX*RX15RW30

Device Problem Device Difficult to Setup or Prepare (1487)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/25/2019

Event Type  malfunction  

Manufacturer Narrative

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.Review of device history records and the shipping inspection record of the involved product/lot# combination was conducted with no relevant findings.(b)(4).

Event Description

The user facility reported that the user started priming the capiox device by running the main pump about 3-4l/min.During recirculating of the cardioplegia line at 250-300ml/min using the cardioplegia port, there was evidence of an air bubble that appeared in membrane oxygenator.The user immediately stopped the pump and changed to a new oxygenator.The user primed the oxygenator with different technique by connecting cardioplegia line to blood outlet using y-connector and there was no more evidence of air bubbles.The case was successful, and patient was reported to be safe.The event occurred pre-treatment.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide the device return date in concomitant medical products, update device evaluated by mfr, and to provide the completed investigation results.Adverse event problem- results - 114 is based upon the evaluation of user facility information and the investigation of the provided movie; 213 is based upon functional testing of the returned sample.-conclusion - 4310 is based upon evaluation of the user facility information and the investigation of the provided movie; 67 is based upon functional testing of the returned sample.The actual sample was returned for evaluation.A video was provided for inspection.The movie provided by the user showed air bubble in the oxygenator.Visual inspection revealed that the luer thermistor on the blood outlet port side had been broken.As this damage was not mentioned in the complaint, the luer thermistor was considered to have been broken during transportation back to ashitaka factory.No anomaly that could lead to the air bubble entering in the oxygenator was noted in the appearance of the actual sample.The actual sample was rinsed, built into a circuit, and primed with saline solution; circulated by a roller pump in accordance with ifu.No air remained inside the oxygenator.Based on the complaint description, saline solution was circulated in the actual sample under the following circulation conditions: main flow rate (roller pump): 3 - 4l/min; flow rate (cardioplegia side): 250-300ml/min; gas flow rate: 2l/min; blood level inside the reservoir: 250ml.As a result, no entrance of air was confirmed.The reported phenomenon was not reproduced.Three attempts to reproduce the reported event were made using the actual sample as follows: if the roller pump is stopped suddenly, the pressure inside the oxygenator module turns to be negative, air may be pulled into the oxygenator.Based on this knowledge, the roller pump circulating saline solution at the flow rate of 4l/min, which was reported in the complaint, was stopped suddenly.As a result, the pressure inside the actual sample turned to be negative (approx.-30mmhg) and air was pulled into the actual sample.Note: the negative pressure applied to the oxygenator module varies depending on the circulation conditions and/or the circuit specifications.Air may enter the oxygenator when the blood flow rate after the oxygenator is larger than that before the oxygenator, or when the roller pump on the main circuit is stopped.Based on this knowledge, while the pump on the cardioplegia side is running at 300ml/min as reported in the complaint, the pump on the main circuit is stopped.As a result, air entered the oxygenator.Excessive volume of air of over 15ml/min was sent into the gas line to increase the gas line pressure.As a result, air entered the oxygenator.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 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 1l/min.Do not supply gas during priming.Pressure in the blood phase should always be higher than that in the gas phase to prevent gaseous emboli entering the blood phase.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 pressure inside the oxygenator module became negative due to some factors (e.G., sudden stop of the roller pump), and air was pulled inside the oxygenator module through the fibers.It is experientially known that the pressure inside the oxygenator may become negative under the following condition.When the flow of the priming solution into the oxygenator was cut-off by an application of clamp or sudden stop of roller pump, the priming solution inside the oxygenator module can still be flowing out of the oxygenator by inertial force.This may cause the pressure inside the oxygenator to become negative.However, the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: CAPIOX RX15 W/ 3L RESERVIOR (LT. PORT)
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 9346586
• MDR Text Key: 219288593
• Report Number: 9681834-2019-00198
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350771056
• UDI-Public: 04987350771056
• Combination Product (y/n): N
• PMA/PMN Number: K051997
• 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: 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: CX*RX15RW30
• Device Lot Number: 181207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Initial Date Manufacturer Received: 10/31/2019
• Initial Date FDA Received: 11/20/2019
• Supplement Dates Manufacturer Received: 12/04/2019
• Supplement Dates FDA Received: 12/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1