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

Model Number N/A

Device Problem Increase in Pressure (1491)

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

Event Date 01/12/2023

Event Type  malfunction  

Event Description

The user facility reported that within ten (10) minutes of the start of the procedure, pressure rise was detected in the capiox device involved.However, the pressure lowered immediately, and the procedure continued.The patient's blood had a tendency (condition) to clot easily.There was no patient injury or medical/surgical intervention required.The procedure was completed successfully.The final patient impact was not harmed.

Manufacturer Narrative

Patient identifier: requested, unknown.Date of birth & age: requested, unknown.Patient sex: requested, unknown.Weight: requested, unknown.Ethnicity: requested, unknown.Race: requested, unknown.Lot number: 220823.Expiration date: 01/31/2024.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.Pma/510(k) - k1305203.Device manufacture date: (b)(6)2022.Visual inspection of the actual sample upon receipt found no anomaly such as a breakage.The actual sample was filled with physiological saline-containing glutaraldehyde solution and fixed, then the housing and filter were removed.Visual and magnifying inspection of the oxygenation module found no clogging due to blood clots that could lead to pressure rise.There was no abnormality in the winding condition of fibers.The heat exchanger, after separated from the outer cylinder, was subjected to visual and magnifying inspection.There was no clogging due to blood clots that could lead to pressure rise.Review of the manufacturing record and the shipping inspection record of the actual sample found no anomaly in them.A search of the past complaint file found no other similar indication for the involved product code/lots.From the investigation results, no formation of blood clots leading to pressure rise was observed inside the actual sample.The cause of this incident was thought to be the possibility that the aggregation capacity of the blood was activated by some factor, and when such blood flowed into the oxygenator, it clogged the oxygenator, resulting in a temporary increase in pressure drop.However, it was not possible to clarify the factors that activated the aggregation capacity and the factors that led to clogging from the state 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.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.

• 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: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 16324093
• MDR Text Key: 309609752
• Report Number: 9681834-2023-00009
• 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: 02/08/2023

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 Expiration Date: 12/31/2023
• Device Model Number: N/A
• Device Catalogue Number: CX-XRY56102A
• Device Lot Number: 220729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2023
• Initial Date FDA Received: 02/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2022
• 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