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

Model Number N/A

Device Problems Obstruction of Flow (2423); Air/Gas in Device (4062)

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

Event Date 03/20/2023

Event Type  malfunction  

Event Description

The user facility reported that bubbles were found from the reservoir of the capiox device during cardiopulmonary bypass in a case of cardiac tumor resection.There was also a temporary drain failure, and the level became unstable.Although the bubbles in the reservoir did not subside, there was no problem with the gas transfer performance of oxygenator.Therefore, it was used continuously until the completion of cardiopulmonary bypass.There was no patient injury/medical or surgical intervention required.The procedure outcome was completed successfully.The final patient impact was not harmed.

Manufacturer Narrative

Patient identifier: requested, not provided.Age & date of birth: requested, not provided.Patient sex: requested, not provided.Weight: requested, not provided.Ethnicity: requested, not provided.Race: requested, not provided.Udi: n/a as this product code is not exported to the us market.Implanted date: requested, not provided.Explanted date: requested, not provided.Occupation: clinical engineer.510k: k130280.Investigation of the actual sample obtained the following results.Confirmation of the image when the device was in use found that blood was draining from the venous filter above the reservoir's liquid level.Foamy blood was found in the upper part of venous filter.Visual inspection of the actual sample upon receipt found no anomaly such as a breakage.No looseness was found in the cap attached to each port.After disassembling the actual sample, visual inspection of the tube inside the venous filter was performed.No anomaly such as a breakage that could lead to air mixing was found.No anomaly such as a breakage was found at the connecting part between the venous blood inlet port and the tube.Product structure: the tube connecting to the venous line inside the venous filter of the involved product is designed to be submerged at the liquid level.Therefore, when air is drawn in, it accumulates inside the venous filter as foam.Accumulated foam is defoamed by the defoaming material inside the venous filter.In our past experience we have experienced the phenomenon that when air continued to enter from the venous line, the level inside the venous filter rose, and foamy blood flowed out from the upper side of venous filter.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 result, as a possible cause of occurrence, from our past experience, it was likely that since air continued to be drawn from the venous line, bubbles accumulated inside the venous filter, and the foamy blood that could not be completely defoamed by the defoaming material flowed out from the upper side of venous filter.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.

• 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 ; 950 elkton blvd; elkton, MD 21921 ; 6402040886
• MDR Report Key: 16713211
• MDR Text Key: 313165123
• Report Number: 9681834-2023-00085
• 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: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: N/A
• Device Catalogue Number: CX-FX25RWV
• Device Lot Number: 220913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2022
• 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
• Treatment: BLOOD CIRCUIT (JMS)