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

Catalog Number CX-XRY55002

Device Problem Medical Gas Supply Problem (2985)

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

Event Date 01/12/2017

Event Type  malfunction  

Manufacturer Narrative

Udi for this product code is not required to be registered with fda.The actual device was not returned to the manufacturing facility.An unused sample from the reported product code/lot combination was returned to the facility for evaluation.Visual inspection found no anomalies.The sample was tested for its gas transfer performance.No anomalies were revealed and the obtained values met manufacturing specifications.A review of the device history record and the product release decision control sheet of the involved product/lot # combination was conducted with no relevant findings.The user facility reported a similar event for another device with the same product/lot no.Combination, see mdr 9681834-2017-00010 for details.There is no evidence that this event was related to a device defect or malfunction.The sample was confirmed to be normal product with its gas transfer performance meeting specification.Although the exact cause of the reported event cannot be definitively determined based on the available information, the following factors can be inferred: high hb prevented pao2 from rising adequately; and fio2 lower than 100% and insufficient gas flow rate led o2 supply volume to come to be insufficient.The device labeling does address the potential for such an event in the instruction for use (ifu) with the statement such as the following: "start gas supply with v/q=1 and fio2=100%, then make adjustments based on blood gas measurements." (b)(4).All available information has been placed on file in quality assurance for appropriate tracking, trending and follow-up.Actual device not returned.

Event Description

The user facility reported insufficient gas exchange in the capiox device.Follow up communication with the user facility confirmed the following information: the customer used a tubing pack containing the actual fx15 sample; it was reported that circulation followed normal protocol but po2 did not increased as much as expected and co2 removal performance was poor; the customer addressed this issue by controlling the flow rate and decreasing the temperature slightly; the procedure was completed successfully; the amount of blood loss is unknown; and there was no harm to the patient.

• 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
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer Contact: jennifer suh ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 6311118
• MDR Text Key: 66875984
• Report Number: 9681834-2017-00011
• 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
• Type of Report: Initial
• Report Date: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: CX-XRY55002
• Device Lot Number: 160906
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2016
• 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