MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION CAPIOX FX25 OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number N/A

Device Problem Device Sensing Problem (2917)

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

Event Date 10/23/2023

Event Type  malfunction  

Manufacturer Narrative

G4: pma/510(k): k130280; e3: occupation: clinical engineer.Visual inspection of the thermistor probes of oxygenator and of the reservoir obtained the following result.There was no anomaly such as a breakage.No anomaly in the condition of adhesion between the thermistor probes and the ports.The actual sample (after cleaning) was incorporated into a circuit consisting of tubing.While saline solution was circulated through the blood channel, 37°c warm water was flowed into the heat exchanger.The displayed temperature was comparable to that read with a current product and no anomaly was observed.The manufacturing record and the shipping inspection record of the actual sample found no anomaly.No other similar report of the product with the involved product code/lot number was found.Based on the investigation results, no anomaly was found in each thermistor probe of the actual sample, and the cause of the occurrence of this case could not be clarified.Relevant instructions for use (ifu) reference: "do not use if the package or device is damaged (e.G.Cracked) or any of the port caps are off." terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.

Event Description

The user facility reported that the arterial blood temperature and venous blood temperature on the display were unstable and disordered.The problem persisted even after the thermistor cables were replaced with new ones.The pump chart showed that venous blood temperature was unstable, including from 11:16 to 11:19, and the arterial blood temperature was observed unstable around 14:36.The thermistor cables were replaced with new ones.The surgery continued and was completed successfully.The final patient impact was not harmed.

• Brand Name: CAPIOX FX25 OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• 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 ; 4103927218
• MDR Report Key: 18160996
• MDR Text Key: 328416335
• Report Number: 9681834-2023-00220
• 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: 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: N/A
• Device Catalogue Number: CX-FX25RWV
• Device Lot Number: 230525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2023
• 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