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

Catalog Number	CX*RX15RW30
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/01/2018
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 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 the product release decision control sheet of the reported product code/lot number combination was conducted with no findings.A search of the complaint file found no previous report with the involved product/lot# combination.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 when the perfusionist was opening the immediate capiox device box for surgery, they saw a squeezed area in the blood outlet area of the oxygenator.The event occurred pre-treatment and the patient was not harmed.
Additional Manufacturer Narrative
Visual inspection upon receipt found that the cap had been removed from the blood outlet port and the blood outlet port had been crushed inward from the outside.The cap was returned along with the device.The cap was inspected with the naked eye and under magnification.It was found to have some deformed portions on the surface.The blood outlet port on an oxygenator sample, with the cap attached to it, was hit on a hard object.As the result, the cap and the blood outlet port got deformed into the configurations which were similar to those observed on the actual sample.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 actual sample was exposed to some hitting force on the blood outlet port on the oxygenator module, resulting in the reported damage.The exact cause of the reported event cannot be definitively determined based on the available information.

• 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: 7614118
• Report Number: 9681834-2018-00108
• Device Sequence Number: 19388647
• Product Code: DTZ
• UDI-Device Identifier: 04987350771056
• UDI-Public: 04987350771056
• Combination Product (Y/N): N
• Initial Reporter Country: CE
• 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,Followup
• Report Date (Section B): 06/19/2018

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: 04/30/2020
• Device Catalogue Number: CX*RX15RW30
• Device Lot Number: 170519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/01/2018
• Supplement Date Received by Manufacturer: 06/18/2018
• Initial Report FDA Received Date: 06/19/2018
• Supplement Report FDA Received Date: 07/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1