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

Catalog Number CX*FX05RW

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/02/2019

Event Type  Injury  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Health professional: unknown.Initial reporter occupation: unknown.The 510(k): k130520.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.A review of the device history record and product release decision control sheet of the product code/lot# combination was conducted with no findings.(b)(4).

Event Description

The user facility reported that stock from (b)(6); the capiox failed within 3 min of bypass starting.Device was not oxygenating; did manual blood gas as confirmation.They stopped the bypass, and the oxygenator was changed out, and was worked fine.There was no harm to the patient.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide corrections to sections d4 and g5; to update section d10, h3, and to provide the completed investigation.Upon receipt of the actual sample, it was found to be a cx*fx05rw, not the initially reported cx*fx25rw.The involved device was confirmed to be cx*fx05rw, therefore, has been corrected.G5.Pma/510(k): k130280.The actual sample was received for evaluation.Visual inspection revealed a crack on the blood outlet port and a scratch on the blood inlet port on the oxygenator module.There was not any other anomaly, such as a break, in the appearance on the remainders of the device.The actual sample, after having been rinsed and dried, was built into a circuit with tubes and tested for its gas transfer performance in accordance with the factory's shipping inspection protocol.Bovine blood arranged to (hb12.0 g/dl, temp.37oc., ph:7.4, svo2:65% and pvco2:45mmhg) was circulated in the oxygenator module under the following conditions: @ v/q=1, fio2=100% and the flow rate of 2l/min.And 1/min.Result: o2 transfer volume: @2l/min.= 121ml/min.@1l/min.= 69ml/min.Co2 removal volume: @2l/min.= 104ml/min.@1l/min.= 56ml/min.No anomalies were revealed in the gas transfer performance of the actual sample, with the obtained values meeting manufacturer specifications.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 with no issue in the gas transfer performance.However, 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, 418 ; JA 418
• MDR Report Key: 8654138
• MDR Text Key: 146506367
• Report Number: 9681834-2019-00093
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350701046
• UDI-Public: 04987350701046
• 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: 05/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: CX*FX05RW
• Device Lot Number: 180413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2019
• Date Manufacturer Received: 07/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other