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

Model Number	N/A
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E1: initial reporter name: unknown.E1: phone number: unknown.E2: health professional: unknown.E3: occupation: unknown.Confirmation of the provided image found transparent bubbles were found on the gas outlet side.Visual inspection of the actual sample upon receipt found no anomaly such as a breakage.Leak test of the actual sample: the actual sample (after rinsing) was installed into a circuit consisting of tubes, and the colored saline solution was circulated through the actual sample.No leakage was found.The blood outlet port side was clamped, and the inside of housing on the gas channel side was inspected when an air pressure of 2 kgf/cm2 was applied to the blood channel from the blood inlet port side.No leakage was found.The manufacturing record and the incoming inspection record of the actual product found no anomaly.No other similar report of the product with the involved product code/lot number was found.Based on the investigation result, as a possible cause of bubbles found on the gas outlet side, following factors were inferred from our past experience.However, no anomaly that could lead to a leak was found in the actual sample, and the cause of occurrence could not be clarified.The blood properties changed due to some factor, a substance having a surface-active action was produced, and the relationship between the surface tension of blood and gas maintained in the micropores of fiber was broken.This made the fibers hydrophilic, leading to plasma leakage.Liquid adhered to the gas outlet side due to some factor, causing bubbles to form when air was swept.Relevant instructions for use (ifu) reference: "do not use an oxygenator and reservoir that leaks.Replace it with another capiox fx05 oxygenator and reservoir." 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 or Problem Description
The user facility reported leakage with the capiox device involved.During priming, the perfusionist found a lot of bubbles in gas outlet after he added blood to replace crystalloid.There was no patient injury/medical or surgical intervention required.The procedure outcome was not reported.The patient was not harmed.

• Brand Name: CAPIOX FX OXYGENATOR
• Common Device Name: 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 ; 4103927218
• MDR Report Key: 19310208
• Report Number: 9681834-2024-00074
• Device Sequence Number: 6942626
• Product Code: DTZ
• UDI-Device Identifier: 04987350781772
• UDI-Public: 04987350781772
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K071572
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/14/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2025
• Device Model Number: N/A
• Device Catalogue Number: CX*FX05RW
• Device Lot Number: 230119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2024
• Initial Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EXTRACORPOREAL CIRCULATION MACHINE.
• Patient Sex: Unknown