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

Catalog Number	CX*RX15RW30
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/26/2018
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 revealed that the purge line tube's elbow connector that is to be connected to the reservoir had been completely fractured.Magnifying and electron microscopic inspections of the fracture cross-section of the elbow connector did not find any embedded foreign particle or entrainment of air bubbles which would have contributed to the generation of the fracture.On the surface of the fracture cross-section some streaks were noted to have been generated.From these findings, it is assumable that the fracture started at one point and developed further in the direction the streams show.Reproductive testing was performed on a factory-retained elbow connector was connected to the reservoir and instantaneous shock force was applied to the elbow tube from above.The elbow tube got fractured in the similar manner as the actual sample at the same position as that on the actual sample.Magnifying and electron microscopic inspections of the fracture cross-section of the elbow connector found that some streaks similar to those on the actual sample had been generated on the fracture cross-section.A review of the device history record and the product release decision control sheet of the reported product code/lot number combination was conducted with no findings.Ifu reference: do not use if the package or device is damaged (e.G.Cracked) or any of the port caps are off.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 elbow connector of the actual sample was exposed to shock force which exceeded the strength limit of this component form above in the state of being connected to the reservoir, resulting in the reported fracture.However, the exact cause of the reported event cannot be definitively determined based on the available information.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 a fracture was found on the recirculation line joint, before priming the capiox rx15 device.It occurred pre-treatment, and the patient was not harmed.The procedure outcome was reported to be unknown.

• 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: 7989766
• Report Number: 9681834-2018-00193
• Device Sequence Number: 11197336
• Product Code: DTZ
• UDI-Device Identifier: 04987350771056
• UDI-Public: 04987350771056
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K051997
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/22/2018

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: 02/28/2021
• Device Catalogue Number: CX*RX15RW30
• Device Lot Number: 180316C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2018
• Initial Report FDA Received Date: 10/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1