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 12/12/2022

Event Type  Injury  

Manufacturer Narrative

Date of birth: requested, not provided.Ethnicity: requested, not provided.Race: requested, not provided.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.Visual inspection of the actual sample upon receipt found no breakage in the appearance.Physiological saline solution was flowed into the actual sample by gravity.There was no formation of blood clots that could lead to increasing pressure.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 no formation of blood clots that could lead to increasing pressure.There was no anomaly in fiber winding condition.The oxygenation module was inspected visually while the fiber layer was removed gradually.There was no formation of blood clots that could lead to increasing pressure.There was no abnormality in fiber winding condition.The heat exchanger was separated from the outer cylinder and subjected to visual and magnifying inspection.Adhesion of white blood clots throughout the heat exchanger was observed.No deformation that could lead to an obstruction was observed in the heat exchanger.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.During the investigation, adhesion of white blood clots was found adhered to the heat exchanger of the actual sample.The cause of this incident was thought to be the formation of white blood clots in the heat exchanger due to some factor, which may have caused a clogging, resulting in the increasing pressure drop.However, the factors that lead to the formation of white blood clots could not be clarified 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.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).

Event Description

The user facility reported that the pressure before the oxygenator rose about twenty (20) minutes after the start of extracorporeal circulation, peaking at 385 mmhg.Although heparin was added and the pressure gradually dropped to 320 mmhg, the circulation could not be stopped because of the pressure difference, therefore xsa99932 was connected.At 12:42 pm, fx05 was cut out from another new pre-connected kit while maintaining circulation.Exchange was done at 13:11.After the exchange, the pressure difference between the inlet and outlet of the oxygenator was maintained at 70 to 80 mmhg until ecc was completed.Immediately after the start of the surgery, the act was not as elongated and additional infusion was performed from the pump side.No blood clots were observed in the reservoir or cr during the operation.The oxygenator was changed out.While the circulation was maintained by adding an ecmo, the oxygenator in question was replaced with fx05 that was cut out from a pre-connected kit, and the operation was completed.The event occurred intra-operative.There was no patient injury or surgical intervention required.The procedure was completed successfully.The final patient impact was not harmed.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide a correction to section h4.

• 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 ; reg. no. 2243441; 265 davidson ave suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 16122468
• MDR Text Key: 306918879
• Report Number: 9681834-2022-00271
• 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,Followup
• Report Date: 01/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: N/A
• Device Catalogue Number: CX-XRZ35001
• Device Lot Number: 220526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2022
• 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
• Treatment: M SIZE EBS CIRCUIT
• Patient Age: 24 MO
• Patient Sex: Male
• Patient Weight: 9 KG