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

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

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

Event Date 07/19/2023

Event Type  malfunction  

Event Description

The user facility reported that a plasma leak occurred five to six hours after the start of operation.(there was some hemolysis on the way.) since it was the final stage of procedure, the operation was completed without replacing the oxygenator.The patient was not harmed.

Manufacturer Narrative

E3: occupation: clinical engineer g4: pma/510(k) - k130520 1.Investigation of the actual sample: 1.1.Visual inspection of the actual sample upon receipt · no anomaly such as a breakage was found.· it was found that the cross section of fiber inside the housing on the gas channel side had been discolored red.1.2.Gas was swept into the gas channel of actual sample · it was found that a red transparent liquid was flowing out from the gas outlet side.· the liquid that flowed out was confirmed with our protein test paper (uriace).As a result, protein was contained.It was likely that this liquid was plasma that had turned red transparent due to hemolysis.1.3.The actual sample was disassembled for the visual inspection of the internal condition · it was found that a part of the fiber had been discolored.· no anomaly was found in the wound state of fiber.· no anomaly such as an occlusion in the channel was found in the heat exchanger.1.4.Electron microscopic inspection of the fiber in each layer of the actual sample · no anomaly was found in the condition of fiber surface compared to the current product.· the fiber was cut and the condition of inner surface was confirmed.No anomaly was found in the condition of micropores compared to the current product.In addition, it was found that plasma components leaked out from the inner surface of a part of fibers.2.Record review: 2.1.The manufacturing history record and the shipping inspection record of the actual sample · no anomaly was found.2.2.Past complaint file · no other similar report of the product with the involved product code/lot# was found.2.3.Manufacturing date: february 10, 2023 3.Cause of occurrence/conclusion: based on the investigation result, it was confirmed that a plasma leak had occurred in the actual sample.As a possible cause of the plasma leak, from our past experience, the following factor was inferred.However, it was not possible to clarify the cause of plasma leak.· it was inferred that any change in blood properties produced a surface-active substance that disrupted the surface tension relationship between blood and gas that had been maintained in the micropores of the fiber surface.As a result, plasma leak was likely to occur.Relevant ifu reference: "do not use an oxygenator and reservoir that leaks.Replace it with another capiox fx15 oxygenator and reservoir." 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).

• Brand Name: CAPIOX CUSTOM PACK
• 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 ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 17572311
• MDR Text Key: 321680373
• Report Number: 9681834-2023-00161
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2023
• 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-XRY11351
• Device Lot Number: 230210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2023
• 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