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

Catalog Number CX*FX05RW

Device Problem Leak/Splash (1354)

Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597)

Event Date 02/05/2019

Event Type  Injury  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Reporter name:requested, not provided.Health professional: requested, not provided.Occupation: requested, not provided.510(k) no: k130280.The actual device has been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.A review of the device history record of the involved product code/lot number combination revealed no findings.(b)(4).

Event Description

The user facility reported that the involved capiox device outlet luer lock valve leaked.They had to replace oxygenator.The volume of blood loss was reported to be unknown.The procedure outcome was reported to be unknown.There was no harm to the patient.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide corrections to sections and to update and to provide the completed investigation.It was inadvertently reported in section d10 of the initial report that the actual device was returned; however, the actual device had not been returned.Therefore, the correct return date of 29mar2019 has been provided.Section of the initial report had 2199 submitted; however, the correct code 2597 has been provided.The actual device was returned for evaluation.The one-way valve attached to the sampling line connected to the blood outlet port on the oxygenator module was not returned for evaluation.Visual inspection revealed no anomalies, such as a break, in the appearance.The actual sample was rinsed; saline solution was filled in the blood phase with the blood outlet port side clamped and the blood phase was pressurized at 2kg/cm2 from the blood inlet port side.No leak was noted.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 the normal product.However, with no return of the one-way valve, the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: CAPIOX FX OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• MDR Report Key: 8381813
• MDR Text Key: 137526575
• Report Number: 9681834-2019-00027
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350781772
• UDI-Public: 04987350781772
• Combination Product (y/n): N
• PMA/PMN Number: K071572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: CX*FX05RW
• Device Lot Number: 180601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2019
• Date Manufacturer Received: 03/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention