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

Catalog Number CX*FX25RW

Device Problem Device Difficult to Setup or Prepare (1487)

Patient Problem No Patient Involvement (2645)

Event Date 07/23/2020

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Pma/510(k)- k130520.The actual sample was received for evaluation.Visual inspection revealed that the lock adapter had come off the male connector of the sampling system.Magnifying inspection of the actual sample did not find any visible anomaly, including deformity, in the male connector or in the lock adapter.The dimension of each part of the actual sample was measured and confirmed to be equivalent to each part of a factory-retained current product sample.The surface of the male connector was subjected to elemental analysis with sem-edx (scanning electron microscope / energy dispersive x-ray spectroscopy).The result showed presence of some elements including si, which is likely to be derived from the silicone applied to the switch cocks of the sampling system in the manufacturing process to improve the lubricity of them.Reproductive testing was conducted based on the assumption that the lock adapter had come off, when re-tightened, because the male connector was in the state of being lubricated with some material.Silicone was applied to a male connector of a factory-retained sampling system, then a female connector was attached to it and a lock adapter was tightened up.As a result, the lock adapter came off the male connector.A review of the device history record product release judgement record of the involved product code/lot# combination was conducted with no findings.Ifu states: do not use if the package or device is damaged (e.G.Cracked) or any of the port caps are off.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 silicon, which is applied to the switch cocks of the sampling system to improve the lubricity, was transferred to the male connector part due to some factors.Afterward, the lock adapter, when re-tightened, may have got over the rib on the male connector in lubricated state and came off; the lock adapter and the male connecter fit with each other by stepped part provided inside the lock adapter being caught by the rib of the male connecter.Due to this structure, once the lock adapter gets over the rib completely due to some factors, it may come off the male connector.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.During set up the user could not tighten the manifold which was unusual.They decided to not use the item and to change.The item was not used on the patient.

• 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: theresa mussaw ; reg. no. 2243441; 950 elkton blvd.; elkton, md ; 2837866718
• MDR Report Key: 10424327
• MDR Text Key: 204768209
• Report Number: 9681834-2020-00159
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350701046
• UDI-Public: 04987350701046
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K071494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: CX*FX25RW
• Device Lot Number: 190926K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2020
• Date Manufacturer Received: 07/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2019
• 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