MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX25 OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number CX-FX25RWV

Device Problem Increase in Pressure (1491)

Patient Problem Anaphylactic Shock (1703)

Event Date 06/09/2021

Event Type  Injury  

Manufacturer Narrative

Patient identifier - requested, not provided.Age & date of birth - requested, not provided.Patient sex - requested, not provided.Weight - requested, not provided.Ethnicity - requested, not provided.Race - requested, not provided.Udi - not required for product code.Implanted date: device was not implanted.Explanted date: device was not explanted.Pma/510(k)- k130280.The actual sample was received for evaluation.Visual inspection revealed no anomaly including a breakage in the appearance.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 formation of blood clots.The oxygenation module was visually inspected while the fiber layer was removed gradually.Formation of blood clots was observed throughout the oxygenation module.No anomaly was noted in the wound state of fiber.The heat exchanger was removed from the outer cylinder and subjected to visual and magnifying inspections.Formation of blood clots was observed throughout the heat exchanger.Any deformity that could cause any obstruction was not observed in the heat exchanger.A review of the device history record and product-release judgement record of the involved product code/lot# combination was conducted with no findings.No cause of pressure rise could be read from the pump record ifu states: 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.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.The investigation results verified the returned sample was of normal product.It is likely that blood-derived clogging could have occurred due to a combination of the circulation conditions (act, circulation time, etc.) and the patient's blood condition, causing the pressure to rise the exact cause of the reported event cannot be definitively determined based on the available information.Terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).

Event Description

The user facility reported the capiox device was used during the procedure.During induction of anesthesia, the patient went into anaphylactic shock and the blood pressure dropped, therefore pump was started with 570 sec of act.At five minutes after the pump started, the pressure gradient was 80 mmhg, after cooling started, the pressure gradually increased and exceeded 450 mmhg, then the decision was made to replace the oxygenator; the pressure continued to rise during the exchange that took ten minutes, and reached 1000 mmhg.The exchange of oxygenator was completed twenty minutes after the start of the pump, and then the pressure gradient remained stable around 70 mmhg until the pump was off.Platelets were 500,000 before the operation, after pump was off, it was found to have decreased to 150,000.The patient was not harmed.The procedure outcome as not reported.

• Brand Name: CAPIOX FX25 OXYGENATOR
• 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: mary o'neill ; reg. no. 2243441; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 12065289
• MDR Text Key: 258307516
• Report Number: 9681834-2021-00116
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: CX-FX25RWV
• Device Lot Number: 201201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/09/2021
• Initial Date FDA Received: 06/25/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2020
• 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