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

Catalog Number CX-XRY03502A

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/25/2019

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Pma/510k: 510k - k130520.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.A review of the device history record and product release decision control sheet of the product code/lot# combination was conducted with no findings.Based on the involved product code/lot# combination, the fiber lot number built in the actual sample was traced back.In order to see if there was any anomaly in the oxygenator product in which the involved fiber lot# had been built in, the result of the gas transfer performance test conducted on the product with the involved fiber lot# during the shipping inspection process before the release from ashitaka factory was reviewed.The co2 removal performance was confirmed to meet the specifications as follows.Circulation conditions: @ v/q=1, fio2=100% and the flaw rate of 5l/min.And 3l/min.Co2 removal: @5l/min.= 274ml/min.@3l/min.= 189ml/min.Based on the information that the co2 gas was being sent to the operative field during the procedure, it is likely that the value in pco2 in the suctioned blood in the operative field has become high; or suctioning co2 gas and the blood together has led pvco2 to increase.As a possible cause of difficulty in removing co2 from blood, it is likely that a lowered blood temperature made it difficult for co2 gas from being removed from blood; or some anomaly occurred on the gas line.However, with no return of the actual device, the exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).Exemption number e2015022.

Event Description

The user facility reported that the involved capiox pack was used during mics (minimally invasive cardiac surgery), with the flow rate @f 3.6l/min.And arterial blood temperature @32oc, co2 sweep gas was sent to the operative field @3l/min., which was as usual.The user noticed an increase in pco2 up to 50mmhg.He addressed this issue by increasing the flow rate of the gas to be sent to the oxygenator module up to 8l/min.The surgery was completed successfully without change-out of the actual sample.The patient was not harmed.

• 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
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: theresa mussaw ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 8632665
• MDR Text Key: 204091857
• Report Number: 9681834-2019-00076
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: CX-XRY03502A
• Device Lot Number: 190131
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2019
• 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