MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX15; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number	CX*FX15E
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D6: implanted date: device was not implanted d7: explanted date: device was not explanted e1: address - (b)(6) the actual device has not been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.For this reason, evaluation code 11 has been referenced in the conclusions section of h6.A review of the device history record and product release decision control sheet of the involved product code/lot number combination was conducted with no findings.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 that during prime, the tubing was pinched on the arterial sampling line.The product was changed out.The surgery was completed successfully.There was no impact to the patient.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device return date in section, update section, and provide the completed investigation results.The actual sample was returned for evaluation.Visual inspection upon receipt revealed that the sampling line tube had been flattened.Magnifying inspection of the flattened section revealed the presence of several traces of contact on the tube surface.The interval between the traces was found to be approximately 1.5mm in length.The width of the groove made on the housing of the oxygenator module measures approximately 1.5mm.Functional testing was conducted.A sampling line tube sample was intentionally let to be sandwiched between the oxygenator module and the cushion material.A local crush was generated on the tube.The length of the crushed section was found to differ from that of the flattened section on the actual sampling line tube.Based on the investigation findings, it is likely that the sampling line tube of the actual sample was sandwiched between the oxygenator module and an unknown object.Based on the reproductive test result and the packing configuration of the involved product code, it is most unlikely that the tube gets flattened in the same manner as the actual sample during the production and packing processes.It is likely that the flattening occurred on the sampling line tube of the actual sample after the actual sample was taken out of the original unit-box for storage.However, with the storage condition unknown, the exact cause of the reported event cannot be definitively determined based on the available information.The ifu states: "do not use if package and/or device is damaged, or if caps are not in place, although it is most unlikely that this kind of defect occurs during the production, this complaint was shared with the production process to elevate the associates' awareness of their careful packing work with the best attention not to sandwich the sampling line tube between the cushion materials.".

• Brand Name: CAPIOX FX15
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• MDR Report Key: 8077365
• Report Number: 9681834-2018-00206
• Device Sequence Number: 1370801
• Product Code: DTZ
• UDI-Device Identifier: 04987350701183
• UDI-Public: 04987350701183
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K071494
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2018

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*FX15E
• Device Lot Number: 180306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2018
• Initial Date Received by Manufacturer: 10/26/2018
• Supplement Date Received by Manufacturer: 11/22/2018
• Initial Report FDA Received Date: 11/16/2018
• Supplement Report FDA Received Date: 12/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1