MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX 25 HOLLOW FIBER OXYGENATOR AF; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	N/A
Medical Device Problem Codes	Crack (1135); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided.A2: date of birth: 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: initial reporter name: unknown.E1: phone number: unknown.E2: health professional: unknown.E3: occupation: unknown.G4: pma/510(k): k130520.Visual inspection of the actual sample found damage and stress whitening on the reservoir housing.The actual sample was set to a factory-retained holder and subjected to visual inspection.It was confirmed that the damage to the reservoir had occurred in the protrusion that fits into the groove on the holder arm when the holder arm is slid into the holder-insertion port of the reservoir.Upon measuring the thickness of this part of the reservoir, no difference was observed when compared to a current product sample.Based on the description of the event that they heard a noise when slapping the device diagonally to exhaust air, the following simulation tests were carried out using factory-retained reservoirs.The reservoir was attached to the holder and secured with a stopper at the top of the holder in the locked position.Subsequently, a load to tilt the reservoir was applied.No damage occurred to the reservoir due to its secure fixation.The stopper was unlocked, the reservoir was slid to be separated from the stopper, and a load to tilt the reservoir was applied.This resulted in damage similar to that of the actual sample.Based on the investigation results, including the findings from the simulation test, and on the description of the event mentioned above, it can be inferred that the part of the reservoir that fitted into the groove of the holder arm was subjected to an excessive load, resulting in the damage observed.However, it was not possible to clarify the cause based on the condition of the actual sample.Relevant instructions for use (ifu) reference: "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 during priming, the perfusionist heard an abnormal noise and detected a crack.According to the feedback of the health care professional (hcp), she found that some bubbles were difficult to discharge when she pre-filled to exhaust gas (5l flow rate).She then attempted to slap the device to accelerate the exhaustion; however, it did not take effect.Therefore, she took the device off the bracket and slapped the device diagonally.The she heard some sound of cracking and found the device damaged.The oxygenator and reservoir were not separated to use.The procedure outcome was not reported.The patient was not harmed.There was no patient injury/medical or surgical intervention required.

• Brand Name: CAPIOX FX 25 HOLLOW FIBER OXYGENATOR AF
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• 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: 19828215
• Report Number: 9681834-2024-00129
• Device Sequence Number: 12914770
• Product Code: DTZ
• UDI-Device Identifier: 04987350701046
• UDI-Public: (01)04987350701046(17)261231(10)240111
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/25/2024

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 Model Number: N/A
• Device Catalogue Number: CX*FX25RW
• Device Lot Number: 240111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2024
• Initial Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2024
• 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 Age: 48 YR
• Patient Sex: Male