MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX RX25 OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number CX*RX25RW

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/31/2022

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation - technologist.The actual device was discarded by the user facility and therefore was not available for product evaluation.On june 10, 2022, as additional information a video was provided, in which it was shown that air bubbles were flowing out from the upper part of reservoir.The investigation was performed regarding two phenomena as below.Complaint stated in the ppr: problem occurred while using the oxygenator as during the priming air bubbles was noted coming out of the arterial and cardioplegia outlet of the oxygenator (phenomenon 1).Event filmed on the video: air bubbles were coming out from the upper side of reservoir (phenomenon 2).Phenomenon 1: air bubbles coming out of the arterial and cardioplegia outlet ports of the oxygenator: based on our experience, the following factors are inferred as a cause of air bubbles to flow out of the arterial and cardioplegia outlet ports of the oxygenator during priming.Sudden stopping of the roller pump during priming causes negative pressure to occur inside the oxygenator, which resulted in the air being drawn in through the fibers.Higher flow rate on the cardioplegia side than on the main side causes negative pressure inside the oxygenator, which resulted in the air being drawn in through the fibers.Phenomenon 2: air bubbles coming out of the upper side of reservoir: review of the provided video found that a cap was not attached to the 1/4"-3/8" port, which is located next to the venous blood inlet port, and air bubbles were flowing out.We have experienced this phenomenon caused by the following mechanism.Air bubble continued to enter the venous blood line due to failure to remove venous blood or loosening of the yellow cap at the venous blood port.When the cap on the 1/4"-3/8" port was detached, air bubbles flowed out from the upper part of the venous filter.In the case when air continued to enter from the venous blood line, the air was accumulated as air bubbles inside the venous blood filter, and the air bubbles that could not be defoamed by the defoamer overflowed when the cap on the 1/4"-3/8" was detached.Structure of the reservoir this product is equipped with defoamer inside the venous filter.The air entered the venous filter is defoamed by the defoamer.Review of the manufacturing record and product-release judgement record of the involved product/lot# combination confirmed that there was no indication of anomaly in them.A search of the complaint file did not find any other similar report with the involved product/lot# combination.The investigation found no anomalies in the manufacturing record and product-release judgement record.The following factors were considered as possible causes of the reported event.However, as the actual sample could not be checked, the cause of occurrence could not be clarified.Phenomenon 1: based on our experience, the possibility of negative pressure inside the oxygenator caused air to be drawn in through the fiber was considered; however, the definite cause could not be clarified from the description of the complaint.Phenomenon 2: it was inferred that air continued to enter the venous blood line due to some factors, accumulated as air bubbles in the venous filter, and overflowed from the upper part of the venous filter.Ifu states: 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 20l/min.Excessive gas flow rate will bring about pressure increase in the gas phase, allowing gaseous emboli to enter the blood phase.(warnings) 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.(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 1l/min.(warnings) minimum operating volume in the reservoir is 200ml.Set appropriate blood storage level, relative to venous flow rate, to prevent gaseous emboli passing to patient.(warnings) recirculate the priming solution at a rate of 4l/min or higher to facilitate air removal.Failure to remove air from the oxygenator may result in serious injury to the patient.(b.Priming procedure caution) ensure that the de-airing process is complete prior to initiating bypass.(c.Initiation of bypass caution) (b)(4).

Event Description

The user facility reported that a problem occurred while using the oxygenator as during the priming air bubbles was noted coming out of the arterial and cardioplegia outlet of the oxygenator.The procedure outcome was not reported.The patient was not harmed.

• Brand Name: CAPIOX RX25 OXYGENATOR
• 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: stephanie handy ; reg. no. 2243441; 950 elkton blvd.; elkton, MD 21921 ; 9499890491
• MDR Report Key: 14828299
• MDR Text Key: 295969684
• Report Number: 9681834-2022-00120
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350769572
• UDI-Public: 04987350769572
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K040210
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/27/2022

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 Catalogue Number: CX*RX25RW
• Device Lot Number: 211108
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/31/2022
• Initial Date FDA Received: 06/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2021
• 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 Age: 50 YR
• Patient Sex: Male
• Patient Weight: 60 KG