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

Model Number N/A

Device Problems Crack (1135); Leak/Splash (1354)

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

Event Date 10/04/2022

Event Type  malfunction  

Event Description

The user facility reported that after going on bypass, a leak was noticed from the oxygenator outlet.The oxygenator was examined after the case and a fine crack at the base of the outlet was discovered.The event occurred intra-operative.There was no patient injury/medical or surgical intervention required.The final patient impact was no harm.The procedure outcome was not reported.

Manufacturer Narrative

Lot number: 201223.Expiration date: 11/30/2023.Udi: n/a, as this product code is bulk product.Implanted date: requested, not provided.Explanted date: requested, not provided.Initial reporter phone number: unknown.Initial reporter occupation: clinical perfusionist.Pma/510(k) - k130520.Device manufacture date: 12/23/2020.The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.Review of the manufacturing record and the shipping inspection record of the actual product confirmed that there were not any indications of anomaly in them.A search of each complaint file found no other similar report for the involved product code/lot number combination.(b)(4).

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide the device return date in section d9, and to provide the completed investigation results.The lot number was confirmed to be 201211.Investigation of the actual sample and the provided image confirmed blood was adhered to the blood outlet port.It was found that the connected tube was fixed with a tie band.A mark was found on the end of tube as if it had been once fixed with a tie band.A scratch was found in the blood outlet port.Visual and magnifying inspections of the actual sample found that the actual sample upon receipt was in a state where the tube was removed.A scratch was found in the blood outlet port.In addition, it was found that it had been slightly deformed.Leak test of the actual sample found that the sample was installed into a circuit consisting of tubes, and saline solution was circulated with a flow rate of 5 l/min.No leakage was found.After the blood channel was filled with colored saline solution, the blood outlet side was clamped, and pressure of 2 kgf/cm2 was applied from the blood inlet side into the blood channel.No leakage was found.The manufacturing record and the shipping inspection record of the actual sample found no anomaly.No other similar report of the product with the involved product code/lot# from other facilities was found.Based on the investigation result, no leakage was confirmed found in the actual sample.In ashitaka factory, 100% leak test, and 100% visual inspection at the time of attaching a cap to the port are performed.Therefore, it was not possible to determine when the scratch occurred from the condition of actual sample, and it was not possible to clarify the causal relationship with the leakage.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.(a.Set-up, caution)." "do not use an oxygenator and reservoir that leaks.Replace it with another capiox fx15 oxygenator and reservoir.(b.Priming procedure warnings)"."band all connections in the circuit.(a.Set-up)".

• 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: 15650201
• MDR Text Key: 306917639
• Report Number: 9681834-2022-00215
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: N/A
• Device Catalogue Number: ZZ*FX15RE40
• Device Lot Number: 201211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2020
• 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