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

Model Number N/A

Device Problem Obstruction of Flow (2423)

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

Event Date 06/30/2022

Event Type  Injury  

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.Occupation - clinical engineer.Pma/510(k) - k130520.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.Review of the manufacturing record and the product-release judgment record of the involved product/lot number combination confirmed that there were not any anomalies in them.A search of the complaint file found no other similar reports with the involved product code/lot number combination.The following possibilities were considered to be the cause of the occurrence based on the description of the event, however, as the actual sample was not returned, the cause of occurrence could not be clarified from the results of the investigation.From the description of the event that the hemostasis protocol could not be performed after the administration of protamine and therefore the pump re-started, it was inferred that blood containing protamine was flowed into the thorax.Due to such blood having been suctioned and poured into the cr filter, it became clots clogging the cr filter.Relevant instructions for use (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." (b)(4).

Event Description

The user facility reported that hemiarch replacement was performed for acute aortic dissection.Once the patient was weaned off, the pump was re-started as hemostasis could not be controlled.The anesthetist had administered protamine.The pump was re-started after heparin was administered again and act was confirmed to have been prolonged.However, cr filter became full of clots and the reservoir was changed out.There was no patient injury/medical or surgical intervention required.The final patient impact was not harmed.

• Brand Name: CAPIOX CUSTOM PACK
• 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: stephanie handy ; reg. no. 2243441; 265 davidson ave suite 320; somerset, NJ 08873 ; 9499890491
• MDR Report Key: 15073263
• MDR Text Key: 296290898
• Report Number: 9681834-2022-00137
• 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: 07/21/2022

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 Expiration Date: 05/31/2023
• Device Model Number: N/A
• Device Catalogue Number: CX-XRX51804
• Device Lot Number: 211221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/05/2022
• Initial Date FDA Received: 07/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2021
• 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: CDI550.