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

Catalog Number CX-XRX14501

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/22/2016

Event Type  malfunction  

Manufacturer Narrative

Udi number for this product code is not required to be registered.The actual device has been returned to the manufacturing facility for evaluation.Visual inspection found that the adaptor connected to the female elbow was damaged.An attempt to remove the female elbow connector was made.Visual inspection of the female elbow connector confirmed no anomalies.Visual inspection of the luer male port that was attached to the female elbow confirmed no anomalies.The taper of the female elbow connector and the luer male port on the reservoir were checked respectively with the luer taper gauge and confirmed to meet manufacturing specification.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.A search of the complaint file did not find any other report with the involved product code/lot# combination.There is no evidence that this event was related to a device defect or malfunction.The results of the investigation verified that the actual sample was normal product.(b)(4).All available information has been placed on file in quality assurance for appropriate tracking, trending and follow-up.

Event Description

The user facility reported a bad connection during the use of the capiox device.Follow up communication with the user facility confirmed the following information: during set-up, the customer reported difficulty in removing the luer connector on the purge line of the reservoir; forceps were used to remove the connector; the luer connector became cracked; no leak was noted at the crack of the luer connector; circulation was completed with no issue; the procedure was completed; and the patient was not harmed.

• Brand Name: CAPIOX FX OXYGENATOR
• Type of Device: OXYGENATOR
• 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: 5966184
• MDR Text Key: 55274790
• Report Number: 9681834-2016-00221
• 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: 09/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: CX-XRX14501
• Device Lot Number: 160525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/22/2016
• Initial Date FDA Received: 09/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2015
• 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