MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX RX15 W/ 3L RESERVIOR (LT. PORT); OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number	CX*RX15RW30
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of birth - requested, not provided.Ethnicity - requested, not provided.Race - requested, not provided.Implanted date: device was not implanted.Explanted date: device was not explanted.Phone number- requested, not provided.A reservoir, an oxygenator module, a support arm, and a clip that connects the oxygenator module /reservoir and the support arm, were received for evaluation.Visual inspection revealed that the oxygenator module was found to have come off the support arm.Visual inspection of the reservoir-side connector of the supporter arm did not find any anomaly such as deformity or break in the appearance.Visual inspection of the oxygenator-side connector of the supporter arm found it had been partially broken.Visual and magnifying inspection of the clip found the pawls had been deformed.Reproductive testing was performed.A factory-retained product sample contained in a unit box was dropped by gravity from 1.5 m-high.The oxygenator module did not come off the supporter arm.A factory-retained product sample contained in a unit box was dropped by gravity from 3.5 m-high.The oxygenator module got come off the supporter arm.Review of device history records and the shipping inspection record of the involved product/lot# combination was conducted with no relevant findings.Ifu states: do not use if the package and/or device is damaged or any of caps are off.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.It is likely that the actual sample was exposed to significant shock force beyond the product strength during transportation or storage.However, the exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).
Event or Problem Description
The user facility reported that the connection between the capiox oxygenator and reservoir was broken.The event occurred pre-treatment, and the patient was not harmed.The procedure outcome was not reported.

• Brand Name: CAPIOX RX15 W/ 3L RESERVIOR (LT. PORT)
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 9509643
• Report Number: 9681834-2019-00221
• Device Sequence Number: 10867920
• Product Code: DTZ
• UDI-Device Identifier: 04987350771056
• UDI-Public: 04987350771056
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 12/23/2019

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: 04/30/2022
• Device Catalogue Number: CX*RX15RW30
• Device Lot Number: 190522C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2019
• Initial Report FDA Received Date: 12/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 6 YR
• Patient Weight: 15