MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA BABY FX OXY W/HR & ART FILTER; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number N/A

Device Problem Leak/Splash (1354)

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

Event Date 02/21/2023

Event Type  malfunction  

Manufacturer Narrative

Patient age, date of birth, sex, weight, ethnicity & race: requested, unknown.Device implanted/explanted date: requested, not provided.Initial reporter occupation: chief perfusionist.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.The manufacturing record and the shipping inspection record of the actual product found no anomaly.No other similar report of the product with the involved product code/lot number was found.Terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).

Event Description

The user facility reported that the oxygenator involved leaked.Air bubbles were passing across the fiber bundle which indicated a severe fiber leak.The issue occurred during priming.The event did not result in delay in the beginning or continuing of the surgical procedure.The product was changed out.The surgery was completed successfully.The product malfunction did not cause or contribute to an injury or death.No blood loss was reported.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide the device return date in section d9, update section h3, and to provide the completed investigation results.Visual inspection of the actual sample found no anomaly such as a breakage.Leak test of the actual sample was installed into a circuit consisting of tubes, and colored saline solution was circulated with a flow rate of 1.5 l/min.No air mixing or leakage was found.After the blood channel was filled with colored saline solution, the blood outlet side was clamped, and pressure of 2 kgf/cm2 was applied from the blood inlet side into the blood channel.No leakage was found.The manufacturing record and the shipping inspection record of the actual sample found no anomaly.Past complaint file found no other similar report of the product with the involved product code/lot number was found.Based on the investigation result, no anomaly such as a leakage that could lead to air mixing was found in the actual sample.As a possible cause of occurrence, it was inferred that air flowed into the oxygenator for some reason (e.G., negative pressure of the oxygenator).However, no anomaly was found in the returned sample, and the cause of this case could not be clarified.The instructions for use (ifu) (capiox fx05) has the following warnings and initiation of bypass regarding air mixing and leakage: "do not use an oxygenator and reservoir that leaks.Replace it with another capiox fx05 oxygenator and reservoir.(b.Priming procedure warnings)"."ensure that the de-airing process is complete prior to initiating bypass.(c.Initiation of bypass)"."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)"."do not obstruct gas outlet port.Avoid buildup 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 5l/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 0.5l/min.(warnings)".

• Brand Name: BABY FX OXY W/HR & ART FILTER
• 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: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 16566790
• MDR Text Key: 312033422
• Report Number: 9681834-2023-00049
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350739087
• UDI-Public: 04987350739087
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 1CX*FX05RW
• Device Lot Number: 220307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2022
• 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