MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION CAPIOX FX25 OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number N/A

Device Problem Leak/Splash (1354)

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

Event Date 11/10/2023

Event Type  Injury  

Event Description

The user facility reported that extracorporeal circulation was performed in an avr and cabg case.Four hours after starting ecc, a plasma leak occurred.They managed to wean while adjusting gas exchange, however, re-pump was decided, and the oxygenator was changed out to resume ecc.After the exchange, in three and a half hours, a plasma leak occurred again.The product was changed out due to plasma leak.Ecmo was introduced and the patient returned to icu.The procedure outcome was not reported.The final patient impact was not harmed.

Manufacturer Narrative

A1: patient identifier: requested, not provided.A2: age & date of birth: requested, not provided.A3: patient sex: requested, not provided.A4: weight: requested, not provided.A5: ethnicity: requested, not provided.A6: race: requested, not provided.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: pma/510(k): k130520.Visual inspection of the sample (as arrived at our site) found no breakage in the appearance.The cross section of fiber inside the housing on the gas channel side had been discolored red.The sample was filled with glutaraldehyde-containing saline solution and fixed, and then disassembled for the visual inspection of the internal condition.The fiber was found discolored.No anomaly was found in the winding condition of fiber.No anomaly such as a blockage of flow path was found in the heat exchanger.Electron microscopic inspection of the fiber in each layer of the sample found plasma components adhering to the surface of the fiber.The fiber was cut for the check of the internal condition.It was confirmed that leakage of plasma components had occurred.No anomaly was found in the manufacturing history record and the shipping inspection record for the product code and lot number.No other similar complaint was reported.Based on the investigation result, it was confirmed that the plasma leak had occurred in the actual samples.As a possible cause of the plasma leak, from our past experience, the following factor was considered.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 instructions for use (ifu) reference: "do not use an oxygenator and reservoir that leaks.Replace it with another capiox fx25 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.

• Brand Name: CAPIOX FX25 OXYGENATOR
• 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 ; 4103927218
• MDR Report Key: 18244708
• MDR Text Key: 329429571
• Report Number: 9681834-2023-00248
• 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: 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: N/A
• Device Catalogue Number: CX-FX25W
• Device Lot Number: 230623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2023
• 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
• Patient Outcome(s): Required Intervention