MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX15; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number N/A

Device Problem Increase in Pressure (1491)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/23/2023

Event Type  Injury  

Event Description

The user facility reported that after setting and priming the product as usual, it was started using.At the start of cpb, approximately 8 minutes after the start of complete extracorporeal circulation, the pressure in the circuit increased (pressure drop of 200 mmhg or more), so we decided to replace the oxygenator immediately.Immediately after restarting cpb after replacing to fx25e, the tube at the cp port came off and approx.400ml of blood was lost.A total of approximately 600ml of blood was lost, including the 200ml of blood lost (for fx15 and tubes in front and behind) during replacement of the oxygenator.Therefore, a transfusion of 4 units was performed.After that, cpb was stabilized and the operation was successfully completed.The case was an ascending replacement.However, since selective cerebral perfusion was unnecessary, extreme hypothermia was not applied.It seems that there was an abnormality in the plt value before the operation (the blood test value was fluctuating).The product was replaced from fx15 to fx25.Due to blood loss, 4 units of blood were transfused.The operation was successfully completed.The patient was ready for extubation in the operating room after surgery, and there were no problems.Blood was lost but not seriously.The product was replaced.The procedure was completed successfully and the patient has recovered.

Manufacturer Narrative

D4: udi: n/a as this product code is not exported to the us market.D6a: implanted date: requested, not provided.D6b: explanted date: requested, not provided.E3: occupation: clinical engineer.G4: pma/510(k) - k130520.The actual sample was returned to the ashitala factory.Investigation of the actual sample: visual inspection of the actual sample upon receipt.No breakage was found.The actual sample was filled with saline solution containing a glutaraldehyde solution and was fixed, the housing and filter were removed, and visual inspection of the gas transfer part was performed.It was found that blood clots were formed.No anomaly was found in the condition of fiber winding.The fiber layer was removed gradually, and visual inspection of the gas transfer part was performed.It was found that greater number of blood clots were formed toward the inner side of gas transfer part.No anomaly was found in the condition of fiber winding.The outer cylinder was removed from the heat exchanger, and visual and magnifying inspections of the heat exchanger was performed.No deformation that could lead to an obstruction was found in the heat exchanger.Record review: the blood test data was confirmed.Although the platelet value recorded the day before the procedure was 33.6 × 104/ul, after the patient was separated from the cardiopulmonary bypass, it fluctuated greatly to 4.6 × 104/ul.The manufacturing record and the shipping inspection record of the actual sample no anomaly was found.Past complaint file no other similar report of the product with the involved product code/lot# was found.Based on the investigation result, it was found that blood clots were formed in the actual sample.As a possible cause of occurrence, it was inferred that blood with activated platelet aggregation flowed into the oxygenator for some reason, and the oxygenator was obstructed.This increased the pressure drop.However, it was not possible to clarify the factors that activated the platelet aggregation ability and the factors that caused obstruction from the condition of actual sample.Relevant ifu reference: "- do not reduce heparin during circulation.Otherwise, blood clotting might occur.- adequate heparinization of the blood is required to prevent it from clotting in the system." 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 FX15
• 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: 17168149
• MDR Text Key: 317631216
• Report Number: 9681834-2023-00119
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071494
• 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: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CX-FX15E
• Device Lot Number: 230221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2023
• 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
• Treatment: CPB CIRCUIT (SENKO MEDICAL INSTRUMENT MFG.)
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 59 KG