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

Model Number N/A

Device Problem Increase in Pressure (1491)

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

Event Date 01/14/2023

Event Type  Injury  

Event Description

The user facility reported that during on-pump, pressure at the venous blood inlet port on the capiox device increased.There was no problem in the gas exchange performance.The blood flow rate was not sufficient; therefore, the oxygenator was changed out.The procedure was performed swiftly, and the patient was not harmed.There was no patient injury or surgical intervention required.The procedure outcome was not reported.The final patient impact was not harmed.

Manufacturer Narrative

Udi: n/a as this product code is not exported to the us market.Implanted date: device was not implanted.Explanted date: device was not explanted.Initial reporter occupation: clinical engineer.Pma/510(k): k130280.The actual device has been returned for evaluation.Visual inspection of the actual sample upon receipt found no breakage in the appearance.Physiological saline solution was flowed by gravity into the actual sample.As a result, formation of blood clots was observed over the oxygenation module entirely.The actual sample was filled with glutaraldehyde-containing saline solution and fixed, and then the housing and the filter was removed.Visual inspection of the oxygenation module found formation of blood clots.There was no anomaly in fiber winding condition.The oxygenation module was inspected visually while the fiber layer was removed gradually.The amount of blood clots was found to be greater the further inside the gas exchange area.There was no anomaly in fiber winding condition.The heat exchanger was separated from the outer cylinder and subjected to visual and magnifying inspection.Blood clots were found sticking all over the heat exchanger.No deformation that could lead to a clogging was observed.Review of the manufacturing record and shipping inspection record of the actual sample found no anomaly in them.A search of the past complaint file found no other similar report with the involved product code/lot number.The investigation result showed formation of blood clots in the actual sample.As for the cause of this event, it was conceivable that blood clots formed due to some factor and clogged the oxygenator, leading to the increasing pressure at the venous blood inlet port.However, it was not possible to clarify the cause of blood clot formation from the condition of the actual sample.Relevant instructions for use (ifu) reference: "do not reduce heparin during circulation.Otherwise, blood clotting might occur.(warnings)." "adequate heparinization of the blood is required to prevent it from clotting in the system.(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).

• Brand Name: CAPIOX FX25 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 ; reg. no. 2243441; 950 elkton blvd.; elkton, MD 21921 ; 6402040886
• MDR Report Key: 16362867
• MDR Text Key: 309391192
• Report Number: 9681834-2023-00010
• 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: 02/13/2023

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 Model Number: N/A
• Device Catalogue Number: CX-FX25REV
• Device Lot Number: 220826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2023
• Initial Date FDA Received: 02/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2022
• 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