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

Model Number N/A

Device Problems Leak/Splash (1354); Decrease in Pressure (1490)

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

Event Date 01/17/2023

Event Type  malfunction  

Manufacturer Narrative

Occupation: clinical engineer.The actual device has been returned for evaluation.Visual inspection of the actual sample found no anomaly such as a brakeage was found.Leak test of the actual sample was conducted.The actual sample was installed into a circuit consisting of tubes, and saline solution was circulated with a flow rate of 1.5 l/min.No leakage was found.Water was circulated in the water channel side.No 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 water channel was filled with colored water, the water outlet side was clamped, and pressure of 3 kgf/cm2 was applied from the water inlet side into the water channel.No leakage was found.The manufacturing record and the shipping inspection record of the actual sample found no anomaly.Past complaint files or other similar report of the product with the involved product code/lot number was found.Based on the investigation result, no anomaly that led to the leakage was found in the actual sample.Since no leakage was found in the actual sample, the cause of occurrence could not be clarified.Relevant ifu reference: "do not use an oxygenator and reservoir that leaks.Replace it with another capiox fx05 oxygenator and reservoir.(b.Priming procedure warnings)" 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 during the priming check of oxygenator circuit it was confirmed that the circuit pressure of the capiox device was intermittently decreasing when the occlusion of roller pump on the arterial side was being adjusted.The method of adjusting the occlusion was a dropping method using an infusion set.There was no problem when the heater-cooler water bath was operated; however, when it was stopped, a gradual decrease in the liquid level was confirmed.The operation was repeated several times; however, the same event occurred.The involved product was not used and was replaced with another oxygenator.The procedure was completed successfully.The final patient impact not harmed.

• 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
• 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: 16373430
• MDR Text Key: 309608862
• Report Number: 9681834-2023-00013
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071572
• 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: 02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2023
• 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: CX-FX05RW
• Device Lot Number: 220825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2022
• 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