MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION CAPIOX FX25 HOLLOW FIBER OXYGENATOR AF; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided a2: age & date of birth: requested, not provided a3a: sex: requested, not provided a3b: gender: requested, not provided a4: weight: requested, not provided a5: ethnicity: requested, not provided a6: race: requested, not provided d6a: implanted date: device was not implanted d6b: explanted date: device was not explanted e1: reporter name : requested, unknown e1: phone number: requested, unknown e2: health professional: unknown e3: occupation: unknown g4: 510k #: k130520 the actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.However, a photograph of the actual device was returned for evaluation.Confirmation of the provided image confirmed that the water port (outlet side) of the oxygenator had been broken off.It was not possible to confirm the condition of the broken area (to see whether there was elongation, molding defect, etc.) from the image.Manufacturing record and the shipping inspection record of the actual sample; no anomaly was found.Past complaint file of the involved product code/lot # , had no other similar complaint reported.Based on the investigation result, no anomaly was found in the manufacturing records of the actual sample.Since the actual sample could not be investigated, the cause of occurrence could not be clarified.The instructions for use (ifu) (capiox fx25) of ashitaka factory includes the following information.Do not use if the package or device is damaged (e.G.Cracked) or any of the port caps are off.If the product is dropped during set-up, do not use it.Replace with another device.Terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).
Event or Problem Description
The user facility reported that the involved capiox fx25 device had deformed connectors to the heater cooler.The event occurred during set-up.There are no delays.The surgery was completed successfully.There was no patient issue and no blood loss reported.The product was changed out.

• Brand Name: CAPIOX FX25 HOLLOW FIBER OXYGENATOR AF
• 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: 19140777
• Report Number: 9681834-2024-00065
• Device Sequence Number: 18101359
• Product Code: DTZ
• UDI-Device Identifier: 04987350701084
• UDI-Public: 04987350701084
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K071494
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/18/2024

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: 03/31/2026
• Device Model Number: N/A
• Device Catalogue Number: 1CX*FX25W
• Device Lot Number: 230427
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/27/2023
• 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