MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX 15 HOLLOW FIBER OXYGENATOR AF; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number	CX*FX15E
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 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 the involved capiox fx oxygenator's water port was misshapen and appeared to be melted.The problem occurred during set up.The product was changed out, and the surgery was completed successfully.The event did not cause serious injury, and there was no blood loss.
Additional Manufacturer Narrative
The actual sample was returned for evaluation.Visual inspection revealed that the water port out was deformed.Reproductive testing was performed on test samples.The water port was exposed to hot air until it became melted and deformed.The configuration of the deformation was confirmed to be different from that observed on the actual sample.The water port was exposed to a pressure until it became deformed.The configuration of the deformation was confirmed to be similar to that observed on the actual sample.Ifu states: if the product is dropped during set-up, do not use it.Replace with another device.There is no evidence that this event was related to a device defect or malfunction.Based on the investigation results, it is likely that the water port out, of the actual sample was exposed to some external force.However, the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: CAPIOX FX 15 HOLLOW FIBER OXYGENATOR AF
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• MDR Report Key: 8440308
• Report Number: 9681834-2019-00039
• Device Sequence Number: 13861376
• Product Code: DTZ
• UDI-Device Identifier: 04987350701183
• UDI-Public: 04987350701183
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K071494
• 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,Followup
• Report Date (Section B): 03/21/2019

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: 05/31/2021
• Device Catalogue Number: CX*FX15E
• Device Lot Number: 180604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2019
• Initial Date Received by Manufacturer: 03/04/2019
• Supplement Date Received by Manufacturer: 03/28/2019
• Initial Report FDA Received Date: 03/21/2019
• Supplement Report FDA Received Date: 04/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1