MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX RX15 HOLLOW FIBER OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number CX*RX15RE40

Device Problem Device Difficult to Setup or Prepare (1487)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/03/2019

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.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 during the priming procedure, the perfusionist noticed an air bubble in the capiox device oxy without a significant reason.She looked for many sources trying to identify the location where air bubbles are entering to oxy, but she did not see nothing related with recirculation lines or stock away open.Before thinking of to change the disposable, she recirculated circuit using high flow 5 l/ min for 1 minute, then she stopped the pump and again noticed air enter the oxy.For this reason, she changed the disposable and use another terumo product of the same code.The procedure outcome was not reported.The patient was not harmed.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide the device return date, update and to provide the completed investigation results.The actual sample was received for evaluation.Visual inspection revealed no anomalies, such as a break, in the appearance.The actual sample was rinsed, and saline solution was filled in the blood phase.With the blood outlet port side clamped, an air pressure of 2kgf/cm2 was applied to the blood phase from the blood inlet port side, while the actual sample being observed for any leak.No leak was confirmed.The actual sample was dried, built into a circuit with tubes and primed with saline solution with the use of a roller pump.No air remained inside the oxygenator.Reproductive testing was performed, and the actual sample was circulated with saline solution with the use of a roller pump at the flow rate of 5l/min, which is the flow rate reported in this complaint as the one the involved customer used, the roller pump was stopped suddenly.The pressure inside the actual sample turned to be negative and air was found to be being pulled into the actual sample (the negative pressure the oxygenator module is exerted varies depending on the circulation conditions and/or the circuit specifications).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.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 actual sample turned to be negative when the involved roller pump was stopped suddenly, and air was pulled into the actual sample through the fibers; a sudden stop of the roller pump and a clamping manipulation can be a factor for the pressure inside the oxygenator module to turn to be negative; it is because these manipulations stop the flow of the priming solution into the inside of the oxygenator module, while the priming solution already contained inside the oxygenator flows out of it due to inertial force.However, the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: CAPIOX RX15 HOLLOW FIBER OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 8874059
• MDR Text Key: 153699494
• Report Number: 9681834-2019-00152
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350771070
• UDI-Public: 04987350771070
• 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: 08/08/2019

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: 10/31/2021
• Device Catalogue Number: CX*RX15RE40
• Device Lot Number: 181112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2019
• Initial Date Manufacturer Received: 07/16/2019
• Initial Date FDA Received: 08/08/2019
• Supplement Dates Manufacturer Received: 08/19/2019
• Supplement Dates FDA Received: 09/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR