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

Catalog Number CX-XRX35920

Device Problem Infusion or Flow Problem (2964)

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

Event Date 02/04/2021

Event Type  malfunction  

Manufacturer Narrative

Udi - not required for product code.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.A review of the device history record and product-release judgement record of the involved product code/lot# combination was conducted with no findings.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.It is likely that blood clots were formed and clogged the cr filter due to blood with activated coagulation factors flowed into the reservoir; blood clots and tissue fragment sucked from the surgical field flowed into the reservoir, resulting in the clogging.However, with no device return 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 device was used during the procedure.It was a thoracic aorta case.In less than 30 minutes from the start of circulation, the cr filter of the reservoir rr40v clogged, the pressure at the cr part increased, and suction became impossible.Another rr40v was added and used as cr.It was connected to the 3/8 port next to the inlet port.The procedure outcome was not reported.The patient was not harmed.

• Brand Name: CAPIOX FX25
• 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; 265 davidson ave suite 320; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 11357330
• MDR Text Key: 238927661
• Report Number: 9681834-2021-00015
• 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: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: CX-XRX35920
• Device Lot Number: 201110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2020
• 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