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

Catalog Number CX-XRX53402A

Device Problem Decrease in Pressure (1490)

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

Event Date 09/07/2021

Event Type  Injury  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Initial reporter: occupation - clinical engineer.Pma/510(k) - k130520.The actual sample was received for evaluation.Visual inspection revealed no breakage or other anomaly in the appearance.The actual sample was rinsed with normal saline flowed by head, and then the oxygenation module was inspected visually.Formation of blood clots was observed; however, it was not possible to clarify when the clots formed (at the time of use or during return).The actual sample was fixed by being filled with glutaraldehyde-containing normal saline, and then the housing and the filter were removed.Visual inspection of the oxygenation module found no formation of blood clots.The oxygenation module was visually inspected while the fiber layer was removed gradually.No blood clots were observed.No anomaly was noted in the winding state of fiber.The heat exchanger was removed from the outer cylinder and subjected to visual and magnifying inspections.No deformity or other anomalies that could lead to a clogging were observed in the heat exchanger.The filter and fiber were inspected under an electron microscope.Adhesion of blood cell components including red blood cells, deformed red blood cells (echinocyte), and white blood cells, and formation of fibrin net were observed.A review of the device history record and the product-release judgement record of the involved product code/lot# combination was conducted with no findings.Ifu states: prior to resuming bypass, set fio2 at 100% to ensure adequate oxygenation.Increased pco2 and decreased po2 in the patient's blood at the beginning of recirculation may not be able to be recovered without appropriate gas supply.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.There was a slight clot formation in the oxygenator.In addition, adhesion of blood cell components such as red blood cells, deformed red blood cells (echinocyte), and white blood cells were observed on the filter and fibers.However, as the amount of blood clots was not considered to be enough to affect the gas exchange performance, the cause of the decrease in gas exchange performance could not be clarified.The exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).

Event Description

The user facility reported the capiox custom pack was used during the procedure.A decrease in oxygenation was observed during use in the operation.Specifically, after shifting from partial bypass to total bypass, there was a marked decrease in pao2 (from 300 - 400 to 160).They tried to cope with this by increasing the gas flow rate, but oxygenation did not return to normal even when the flow rate was increased to about 10l.Finally, they replaced the artificial lung.There was dysfunction due to defective gas exchange performance.The patient was not harmed.The procedure outcome was not reported.

• 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
• MDR Report Key: 12561712
• MDR Text Key: 280945731
• Report Number: 9681834-2021-00164
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K071494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 10/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: CX-XRX53402A
• Device Lot Number: 210319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2021
• Date Manufacturer Received: 09/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other