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

Catalog Number CX*FX25RW

Device Problem Leak/Splash (1354)

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

Event Date 03/25/2022

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation - chief perfusionist.Pma/510(k)- k071494, k130520.The actual device has not returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.Review of the provided image of the actual product confirmed the leak from the purge.A review of the manufacturing record and the product release judgement record of the involved product/lot# combination confirmed there was no indication of anomaly in them.A search of the complaint file found no similar report with the involved product code/lot# combination from other facilities.Since no anomaly was confirmed in the manufacturing related records, it is considered at this stage that this was not a product problem.(b)(4).

Event Description

The user facility reported that at the at the time of priming the fx 25 oxygenator with crystalloid fluid, there was a clear leakage from the oxygenator recirculation line at the proximal point of the oxygenator.It seems the connector was broken resulting in fluid leakage from the recirculation line.The oxygenator got replaced before the initiation of cpb.The event occurred pre-treatment.The patient final impact was not harmed.There was no patient injury, medical/surgical intervention required.

Manufacturer Narrative

This report is being submitted as follow-up no.1 to update section d9, update section h3, and to provide the completed investigation results.In the initial report it was reported that the actual sample was available for returned however the actual sample is no longer available.As a cause of occurrence, it was inferred that the actual sample was exposed to a strong impact load during being handled in the distribution period, which resulted in a crack of the sampling line tube leading to the leakage.Since the actual product was not returned for the investigation, however, the definite cause of occurrence could not be determined.Relevant ifu (instructions for use) reference: "do not use if the package or device is damaged (e.G.Cracked) or any of the port caps are off.(a.Set-up, caution)" "do not use an oxygenator and reservoir that leaks.Replace it with another capiox fx25 oxygenator and reservoir.(b.Priming procedure warnings)" "if the product is dropped during set-up, do not use it.Replace with another device.(a.Set-up, caution)".

• 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: stephanie handy ; reg. no. 2243441; 950 elkton blvd.; elkton, MD 21921 ; 9499890491
• MDR Report Key: 14163447
• MDR Text Key: 289756524
• Report Number: 9681834-2022-00065
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350701046
• UDI-Public: 04987350701046
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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,Followup
• Report Date: 04/20/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: CX*FX25RW
• Device Lot Number: 210831
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2022
• Initial Date FDA Received: 04/20/2022
• Supplement Dates Manufacturer Received: 05/11/2022
• Supplement Dates FDA Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/31/2021
• 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 Age: 62 YR
• Patient Sex: Male
• Patient Weight: 79 KG