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

Model Number N/A

Device Problem Obstruction of Flow (2423)

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

Event Date 05/10/2023

Event Type  Injury  

Manufacturer Narrative

D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.G4: pma/510(k): k130520.The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.Review of the manufacturing record and the shipping inspection record of the actual sample: no anomaly was found.Review of the past complaint file of the involved product code/lot : no other similar report regarding the involved product code/lot# was found.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 on may 10th, during the cardiac surgery of patient (b)(6), we experienced a blood clotting episode upon entering extracorporeal circulation.I report that the complication occurred despite following safety protocols, with a activated clotting time (act) of 888 seconds.Therefore, we proceeded with the replacement of materials for patient safety and the continuation of the surgical procedure.The procedure outcome was not reported.The patient was not harmed.Serious injury since the product in question was changed out.

Manufacturer Narrative

This report is being sent as follow-up # 1 to update section d9 and section h3, and to provide the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.1.Review of the provided video: the provided video showed that blood clots were formed on the defoamer of the venous filter inside the reservoir.2.Cause of occurrence/conclusion based on our experience, it was inferred that the following factors could have combined to cause the reported issue; however, the actual sample could not be confirmed, and the cause of occurrence could not be clarified.- our reservoir is designed to structurally stabilize the liquid surface of blood stored in the reservoir in order to make it easier to manage the liquid level.On the other hand, the reservoir has a characteristic that makes it difficult to agitate the blood in the reservoir.- in this case, blood with activated blood-clotting factor flowed into the reservoir and accumulated at the liquid level, resulting in the formation of blood clots.Relevant ifu reference: "- do not reduce heparin during circulation.Otherwise, blood clotting might occur.(warnings) - adequate heparinization of the blood is required considering patient condition and perfusion technique to prevent it from clotting in the system.(warnings)" 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 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 ; 6402040886
• MDR Report Key: 17123665
• MDR Text Key: 317129285
• Report Number: 9681834-2023-00117
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350701046
• UDI-Public: 04987350701046
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2023
• 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*FX25RW
• Device Lot Number: 221208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2022
• 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
• Patient Outcome(s): Other