MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA 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 10/04/2022

Event Type  malfunction  

Manufacturer Narrative

Patient identifier: requested, unknown.Date of birth: requested, unknown.Ethnicity: requested, unknown.Race: requested, unknown.Occupation: perfusionist.Pma/510(k) - k130520.The actual device was not available; therefore, the actual device will not be returned for evaluation.Review of the manufacturing record and the shipping inspection record of the actual sample confirmed that there was not any anomaly in them.A search of the complaint file found no other similar report with the involved product code/lot number combination.According to the investigation result, no anomaly was found in the manufacturing records of the actual sample.Since the actual sample was not returned and the analysis of it could not be performed, the cause of occurrence could not be clarified.Relevant ifu reference: "do not use an oxygenator and reservoir that leaks.Replace it with another capiox fx15 oxygenator and reservoir." (b)(4).

Event Description

The user facility reported that the capiox fx15 oxygenator involved leaked at the connector site during priming.The event occurred pre-treatment.There was no patient involvement.The procedure outcome was not reported.The final patient impact was not harmed.

• Brand Name: CAPIOX FX25 OXYGENATOR
• 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: 15623742
• MDR Text Key: 303555260
• Report Number: 9681834-2022-00218
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350701121
• UDI-Public: 04987350701121
• Combination Product (y/n): N
• Reporter Country Code: SA
• 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: 10/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: N/A
• Device Catalogue Number: CX*FX15RW40
• Device Lot Number: 210420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2021
• 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 Sex: Male
• Patient Weight: 49 KG