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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device is not available for return; therefore, an evaluation of the actual device was unable to be conducted.1.Confirmation of the provided image: - the fitting between the oxygenator and the support arm was disengaged.- the reported breakage of tube could not be confirmed from the provided image.2.Manufacturing record and the shipping inspection record of the actual sample: - no anomaly was found.3.Past complaint file of the involved product code/lot number: - no other similar report was found.4.Manufacturing date: october 27, 2023.5.Expiration date: september 30, 2026.6.Udi no.:(b)(4).7.Cause of occurrence/conclusion: it was thought that the actual sample might have been damaged due to having been subjected to some kind of strong impact load exceeding its limit strength during distribution or storage; however, since the actual sample could not be confirmed, the cause could not be clarified.Relevant ifu reference: "if the product is dropped during set-up, do not use it.Replace with another device.(a.Set-up, caution)".Terumo medical products (tmp) (importer) registration no.2243441 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 it was found that the tube was broken at the connection during the examination before the operation.The procedure outcome was not reported.The patient was not harmed.

• Brand Name: CAPIOX RX OXYGENATOR
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 4103927218
• MDR Report Key: 19319769
• Report Number: 9681834-2024-00082
• Device Sequence Number: 7659629
• Product Code: DTZ
• UDI-Device Identifier: 04987350769572
• UDI-Public: 04987350769572
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K040210
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/15/2024

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: 09/30/2026
• Device Model Number: N/A
• Device Catalogue Number: CX*RX25RW
• Device Lot Number: 231027
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2024
• Initial Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown