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

Catalog Number	CX*RX25RE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D6: implanted date: device was not implanted d7: explanted date: device was not explanted the actual device was returned for evaluation.Visual inspection upon receipt revealed that the gas outlet port had been deformed into a crushed shape.The factory-retained sample of the involved product code/lot# combination was inspected with the unaided eye and confirmed to have no anomaly.Functional testing was conducted.The gas outlet port of an oxygenator sample was hit against a hard object.As the result, the gas outlet port became crushed inward.The damage was similar to that on the actual sample was duplicated.A review of device history records and the product release decision control sheet of the involved product/lot# combination was conducted with no relevant findings.There is no evidence that this event was related to a device defect or malfunction.Based on the investigation result, it is likely that the gas outlet port of the actual sample was hit against a hard object and got deformed.However, it is difficult to determine when and how the actual sample was exposed to the hitting force.The ifu states: "do not use if the package or device is damaged (e.G.Cracked) or any of the port caps are off." terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.Exemption number e2015022.
Event or Problem Description
The user facility reported breakage on the involved capiox rx25 device.The outlet was deformed.During installation of the equipment, the perfusionist evidenced that the gas outlet luer is hidden at less than 50% and he considers that the oxygenator is not in adequate conditions for use.The procedure outcome is unknown.The patient was not harmed.

• Brand Name: CAPIOX RX OXYGENATOR
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• MDR Report Key: 8150019
• Report Number: 9681834-2018-00220
• Device Sequence Number: 13859391
• Product Code: DTZ
• UDI-Device Identifier: 04987350769558
• UDI-Public: 04987350769558
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K040210
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/11/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: CX*RX25RE
• Device Lot Number: 180126K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 12/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1