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

Catalog Number	CX*RX15RW30
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4: udi - not yet required for the reported product code/lot number combination, however the di was provided.The actual device was discarded by the involved facility.Therefore the investigation was limited to user facility information and evaluation of a retention sample from the involved product code/lot number combination.Visual inspection revealed no defects.The connection ring was removed from the support arm fur further visual inspection.The connection ring, the components to fix the connection ring on the reservoir and on the oxygenator module were confirmed to be intact.A review of the device history records and product release decision control sheet of the involved product code/lot # combination was conducted with no relevant findings.A search of the complaint file found no other report with the involved product code/lot# combination.The investigation results verified that the retention was normal product.There is no evidence that this event was related to a device defect or malfunction and the exact cause for the reported event cannot be definitively determined.The device labeling does address the potential for such an occurrence in the instruction for use (ifu) with the statement such as the following: "do not use if the package or device is damaged (e.G.Cracked) or any of the port caps are off.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.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.H3 other text : device discarded by facility.
Event or Problem Description
The user facility reported breakage on the capiox rx15 device.Follow up communication with the user facility reported the following information: when the perfusionist visually checked the oxygenator, he realized that the support between the oxygenator and the reservoir was loose and the oxygenator was moving; the product was replaced and a backup unit was used for the procedure; the reported issue was found out of box and not used in a case; and there was no patient involvement.

• 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: 6300205
• Report Number: 9681834-2017-00013
• Device Sequence Number: 16519609
• Product Code: DTZ
• UDI-Device Identifier: 04987350771056
• UDI-Public: 04987350771056
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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
• Type of Report: Initial
• Report Date (Section B): 02/03/2017

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: 06/30/2019
• Device Catalogue Number: CX*RX15RW30
• Device Lot Number: 160704
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2017
• Initial Report FDA Received Date: 02/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1