MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION CAPIOX FX15; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number N/A

Device Problems Gas Output Problem (1266); Pressure Problem (3012)

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

Event Date 06/05/2023

Event Type  malfunction  

Manufacturer Narrative

D4: udi:n/a as this product code is not exported to the us market.D6a: implanted date: device was not implanted d6b: explanted date: device was not explanted e3: occupation: clinical engineer g4: 510(k) no:k071572, k130280 1.Inspection of the actual sample: 1.1.The actual sample upon received was subjected to visual inspection, and no breakage was found in it.1.2.The actual sample was circulated with normal saline.When circulated at 4 l/min, which was the maximum flow rate recorded during the case, the pressure drop was found to be approximately 9 mmhg higher than that of a current product sample.1.3.The oxygenator was filled with glutaraldehyde-containing normal saline and fixed, then the oxygenation module was separated from the housing and filter and inspected visually.No anomaly was found in the condition of fiber winding.Formation of white blood clots was observed on thee fiber.1.4.The heat exchanger was removed from the outer cylinder and subjected to visual and magnifying inspections.No deformation that could lead to an obstruction was found in the heat exchanger.2.Record review: 2.1.Review of the pump record found that the blood flow rate dropped at the timing when the pressure increased.2.2.Review of the manufacturing record and the shipping inspection record of the actual sample found no anomaly.2.3.Review of the past complaint file found no other similar report on the involved product code/lot#.2.4.Manufacturing date: november 26, 2022 3.Cause of occurrence/conclusion: according to the investigation results, the formation of white blood clots was observed in the fiber of the actual sample.As a cause of occurrence in this case, it was considered possible that the oxygenator was clogged due to some factors, which resulted in the increasing pressure; however, the cause of the clogging in this case could not be clarified based on the condition of the actual sample.Relevant instructions for use (ifu) reference: 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.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.

Event Description

The user facility reported that the pressure exceeded 350 mmhg during procedure.They watched it for a while, but no sign of decrease was observed.Flow rate dropped down to about 80 % of full flow.No impact on the oxygenation performance.As this phenomenon occurred before the weaning, they continued watching without exchanging the product in question until weaning.The procedure outcome was not reported.The patient was not harmed.

• Brand Name: CAPIOX FX15
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• 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: 17260969
• MDR Text Key: 318606538
• Report Number: 9681834-2023-00104
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CX-FX15RW40V
• Device Lot Number: 221126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2022
• 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