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

Model Number	N/A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The provided video of the actual sample showed transparent red bubbles on the gas-out side of the oxygenator.Visual inspection of the actual sample upon receipt found no anomaly in the appearance such as a breakage.The actual sample was incorporated into a circuit consisting of tubing, and then colored saline was circulated through it.No leakage was confirmed.The blood outlet port was blocked and air pressure of 2 kgf/cm2 was applied to the blood channel from the blood inlet port.No leakage was observed inside the housing at the gas-channel side.Manufacturing record and shipping inspection record of the actual sample found no anomaly.Past complaint file of the involved product code and lot number found no other similar report.From the provided video and the result of the investigation, it was inferred that the bubbles observed on the gas-out side during use was caused due to a plasma leak.As a cause of the plasma leak, based on our past experience, the following possibility was considered; however, the definite cause could not be clarified from the investigation result of the actual sample.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.Relevant instructions for use (ifu) reference: "do not use an oxygenator and reservoir that leaks.Replace it with another capiox rx15 oxygenator and reservoir." (b)(4).
Event or Problem Description
The user facility reported that four (4) hours after cpb was started, the perfusionist discovered bloody fluids had leaked out of the gas outlet of the involved oxygenator, lots of bubbles appeared.There was no patient injury or medical/surgical intervention required.The procedure outcome was not reported.The patient was not harmed.

• Brand Name: CAPIOX RX OXYGENATOR
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city
• 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: 19721722
• Report Number: 9681834-2024-00111
• Device Sequence Number: 8033482
• Product Code: DTZ
• UDI-Device Identifier: 04987350771094
• UDI-Public: 04987350771094
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K051997
• 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): 07/11/2024

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 Model Number: N/A
• Device Catalogue Number: CX*RX15RW40
• Device Lot Number: 240126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2024
• 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
• Patient Age: 48 YR
• Patient Sex: Female