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

Model Number N/A

Device Problem Gas/Air Leak (2946)

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

Event Date 01/31/2024

Event Type  malfunction  

Event Description

The user facility reported that during priming the purge line was leaking with the involved capiox device.The event occurred pre-treatment.There was no patient involvement.The final patient impact was not harmed.

Manufacturer Narrative

A2: date of birth: no patient involvement.A3b: gender: no patient involvement.A4: weight: no patient involvement.A5: ethnicity: no patient involvement.A6: race: no patient involvement.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.Confirmation of the provided image found the purge line of oxygenator was fractured from the port.It was inferred that leakage occurred from this fractured section.We have had past experience that the fracture on the purge line may have been occurred when momentary external force was applied while the product was cold.The local temperature from the serial number of actual product (august 2023) to the date of occurrence (january 2024) was investigated.It was found that the minimum temperature was below zero.The manufacturing record and the shipping inspection record of the actual sample found no anomaly.Past complaint file has no other similar report of the product with the involved product code/lot# was found.Based on the investigation result, no anomaly was found in the manufacturing records of actual product.As a possible cause of fracture on the purge line, based on our past experience, it was inferred that after the product was shipped from the factory, during the distribution process in the cold season, momentary force was applied to the product while it was cooled, causing it to fracture.However, since the condition of damage on the actual product could not be confirmed, it was not possible to identify the cause of this case.Relevant instructions for use (ifu) reference: do not use if the package or device is damaged (e.G., cracked) or any of the port caps are off.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 FX 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: 18813578
• MDR Text Key: 337335184
• Report Number: 9681834-2024-00022
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: Physician
• Type of Report: Initial
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• 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*FX25RW
• Device Lot Number: 230828
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/28/2023
• 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 Age: 72 YR
• Patient Sex: Male