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

Catalog Number CX*RX25RW

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/15/2016

Event Type  malfunction  

Manufacturer Narrative

The actual device has not been returned to the manufacturing facility and the investigation is currently ongoing.A follow up report will be submitted within 30 days from the date that this report was sent.A review of the device history record and product release decision control sheet of the involved product/lot # combination was conducted with no relevant findings.A search of the complaint file found no report of this nature with the involved product/lot# combination.(b)(4).All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.

Event Description

The user facility reported breakage on the capiox device.Follow up communication with the user facility confirmed the following information: a small crack was noticed on the external part of the oxygenator; the procedure was completed successfully; and the patient was not harmed.

Manufacturer Narrative

This report is being submitted as follow up # 1 to provide the returned sample evaluation results.The actual device was returned to the manufacturing facility for evaluation.Visual inspection found a flaw on the surface of the housing of the oxygenator device.There was no other obvious anomalies observed.Magnifying inspection of the flaw found the surface of the housing revealed it had been dented.Ct scanning of the flaw found that the housing wall had not been pierced all the way through to the other side.There is no evidence that this event was related to a device defect or malfunction and the exact cause of the reported event cannot be definitively determined based on the investigation results.The device labeling does address the potential for such an occurrence in the instruction for use (ifu) with the statement such as the following: "inspect the device and package carefully.Do not use if the package and/or device is damaged." all available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.

• Brand Name: CAPIOX RX 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: 5924138
• MDR Text Key: 53795237
• Report Number: 9681834-2016-00219
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350769572
• UDI-Public: 04987350769572
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K040210
• 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,Followup
• Report Date: 09/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: CX*RX25RW
• Device Lot Number: 160420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2016
• 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