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

Model Number N/A

Device Problem Leak/Splash (1354)

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

Event Date 03/16/2023

Event Type  malfunction  

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: n/a as this product code is not exported to the us market.Implanted date: requested, not provided.Explanted date: requested, not provided.Initial reporter occupation: clinical engineer.510k: k130280.Visual inspection of the actual sample upon receipt found no breakage or other anomaly in the appearance.Gas was blown into the gas channel of the actual sample.An outflow of light red liquid was observed from gas-out side.The flowed liquid was subjected to our protein test paper ("uriace") and confirmed to contain protein.This liquid was likely to be plasma that became light red due to hemolysis.The actual sample was disassembled for the visual inspection of the internal condition.It was confirmed that a part of the fiber was discolored.No anomaly was observed in the wound state of fiber.No blockage or other anomaly was observed in the heat exchanger channel.Electron microscopic inspection of each fiber layer found no anomaly in the condition of fiber in comparison with a current product sample.The discolored part of fiber was cut for the inspection of the internal condition.Leakage of plasma components was observed.Review of the manufacturing record and the shipping inspection record of the actual sample found no anomaly in them.A search of the past complaint file of the involved product code/lot found no similar complaint received no similar complaint received.Based on the investigation results, it was confirmed that a plasma leakage had occurred in the actual product.As a cause of the plasma leakage, from our past experience, the following factor was inferred.However, it was not possible to clarify the cause of plasma leakage.It was considered probable that some changes in blood properties caused the production of surfactant substances leading to a breakdown of the relationship between the surface tension of blood and gas retained in the micropores on the surface of the fiber, which resulted in a susceptibility to plasma leakage.Relevant instructions for use (ifu) reference: "a phenomenon called wet lung may occur when water condensation occurs inside fibers of microporous membrane oxygenators with blood flowing exterior to the fibers.This may occur when oxygenators are used for a longer period of time.If water condensation and/or a decrease in pao2 and/or an increase in paco2 is noted during extended oxygenator use, briefly increasing the gas flow rate may improve the performance.Increase gas flow rate, to 20 l/min for 10 seconds.Do not repeat this flushing technique, even if oxygenator performance is not improved." 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 that during a redo-avr case, a leak occurred from the gas-out side of the oxygenator involved about six (6) hours after the pump was started.As it was just before the end of the operation, they continued to use the actual sample until the end after confirming the patient's oxygenation status.The oxygenator was not change out.There was no patient injury/medical or surgical intervention required.The procedure outcome was not reported.The final patient impact was not harmed.

• Brand Name: CAPIOX FX 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: gina digioia ; 950 elkton blvd; elkton, MD 21921 ; 6402040886
• MDR Report Key: 16706723
• MDR Text Key: 312945435
• Report Number: 9681834-2023-00071
• 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: 04/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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-FX25REV
• Device Lot Number: 220926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2023
• Initial Date FDA Received: 04/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2022
• 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: 2% CALCIUM CHLORIDE; HEMOFILTRATION REPLACEMENT SOLUTION; HEPARIN; SODIUM BICARBONATE