MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number CX-FX05RE

Device Problem Leak/Splash (1354)

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

Event Date 12/03/2020

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation: clinical engineer.The actual sample; only a sampling line tube connecting the oxygenator and the sampling system was received for evaluation.Visual inspection revealed a crack at approximately 400 mm from the female connector (at approximately 500 mm from the non-return valve).Normal saline was flowed in the actual sample with a syringe.As a result, it leaked from the crack.No leak was observed in the remainder part of the actual sample.Magnifying inspection of the crack found that it had penetrated the tube wall.In addition, a contact mark was found near the crack.Electron microscopic inspection of the crack revealed that it had a shape suggesting that a sharp object came into contact with that area.A review of the device history record and product-release judgement record of the involved product code/lot# combination was conducted with no findings.Ifu states: do not use an oxygenator and reservoir that leaks.Replace it with another capiox fx05 oxygenator and reservoir.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.It is likely that the leak occurred at the crack in the sampling line tube leading to the sampling system.As a cause of the generation of the crack, it is likely that a sharp object came into contact with the tube surface at some point during being handled from the assembling process to the actual use.However, the exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).

Event Description

The user facility reported that the involved capiox device was used pre-treatment.A leak was found at the sampling line during priming.The leak was observed in the middle of the sampling line that connected the oxygenator and the sampling system.There was no harm to the patient as it was found during priming.They stopped using it, and exchanged the device with a new product.The procedure outcome was not reported.

• Brand Name: CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER
• 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: theresa mussaw ; reg. no. 2243441; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 11063780
• MDR Text Key: 223452338
• Report Number: 9681834-2020-00256
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/23/2020

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 Expiration Date: 05/31/2023
• Device Catalogue Number: CX-FX05RE
• Device Lot Number: 200615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2020
• Initial Date FDA Received: 12/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2020
• 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