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

Catalog Number CX-FX25W

Device Problems Leak/Splash (1354); Detachment of Device or Device Component (2907)

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

Event Date 11/30/2020

Event Type  malfunction  

Manufacturer Narrative

Patient identifier: requested, not provided.Age & date of birth: requested, not provided.Patient sex: requested, not provided.Weight: requested, not provided.Ethnicity: requested, not provided.Race: requested, not provided.Udi: not required for product code.Implanted date: device was not implanted.Explanted date: device was not explanted.Pma/510(k): k130280.The actual sample was received for evaluation.Visual inspection revealed no obvious anomaly including a breakage in the external appearance.As a leak test, the blood channel of the actual sample was filled with colored normal saline, blocked at the blood-outlet side, and then pressurized at 2 kgf/cm2 from the blood-inlet side.As a result, no leak was observed.Subsequently, the water channel of the actual sample was filled with colored water, blocked at the water-outlet side, and then pressurized at 3 kgf/cm2 from the water-inlet side.As a result, no leak was observed.A review of the device history record and the 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 fx25 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.The investigation results verified the returned sample was of normal product.The exact cause of the reported event cannot be definitively determined based on the available information.Terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).

Event Description

The user facility reported that the involved capiox device was used pre-treatment.During priming, a small amount of priming fluid was found leaking from the water-inlet/outlet port.We stopped using the oxygenator and immediately replaced it with fx15.After that, the procedure was completed without any problem.The coupler had not been attached to the water-inlet/outlet port.The procedure was completed successfully.The patient 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: theresa mussaw ; reg. no. 2243441; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 11017979
• MDR Text Key: 227724547
• Report Number: 9681834-2020-00248
• 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: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: CX-FX25W
• Device Lot Number: 200515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2020
• 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