MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX RX25 OXYGENATOR/RESERVOIR (RT PORT); OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number	CX*RX25RE
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.A retention sample of the involved product code/lot number combination was evaluated.Visual inspection revealed no anomaly.The reservoir was fixed to the oxygenator module.The unit box and the sterile bag were found to have no break or no other visible damage in them.Reproductive testing was performed and a factory-retained oxygenator sample in the state of being packed in the unit-box was dropped from a height of 1.5m with each side of the box facing the ground (6-time drops).Subsequently, the unit-box was opened for inspection of the oxygenator packed inside it.The test result showed that the support arm was confirmed to be in place on the oxygenator with no damage generated on the unit-box.A factory-retained oxygenator sample in the state of being packed in the unit-box was dropped from a height of 3.5m with each side of the box facing the ground (6-time drops).Subsequently, the unit-box was opened for inspection of the oxygenator packed inside it.The test result showed that the support arm was found to have come off the oxygenator with some damage generated on the unit-box.Review of device history records and the shipping inspection record of the involved product/lot# combination was conducted with no relevant findings.It is likely that the actual sample was exposed to some shock force beyond the strength limit of this product during transportation or storage.However, with no return of the actual device, the exact cause of the reported event cannot be definitively determined based on the available information.Terumo medical products (tmp) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.
Event or Problem Description
The user facility reported that the capiox cardiotomy reservoir detached from the oxygenator, due to the bonding clip that came off from the oxygenator.It happened before bypass; during bypass circuit setup.They used another rx25 oxygenator from stock to manage that case.There was no patient involved.

• Brand Name: CAPIOX RX25 OXYGENATOR/RESERVOIR (RT PORT)
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 9289603
• Report Number: 9681834-2019-00188
• Device Sequence Number: 2030695
• Product Code: DTZ
• UDI-Device Identifier: 04987350769558
• UDI-Public: 04987350769558
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: K040210
• 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): 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: CX*RX25RE
• Device Lot Number: 180709K
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2019
• Initial Report FDA Received Date: 11/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention