MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION CAPIOX FX 15 HOLLOW FIBER OXYGENATOR AF; 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	01/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Terumo medical received an email via distributor medilans from kemerovo scientific research institute on the broken oxygenators.The problem was detected when unpacking oxygenators from the outer package.On two samples from the same box, there was a broken purge line port and disconnected purge line at the place of its connection with oxygenator body.According to chief of anesthesiology department, this could not be occurred during transportation (no visible signs) or removing oxygenator from the box.The vent occurred pre-treatment.There was no patient involved.The procedure outcome was not reported.
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted; d6b: explanted date: device was not explanted.H6: investigation findings - code 3252 is based upon the evaluation of user facility information and the investigation of the images received; code 3221 is based upon no sample returned.The actual sample was discarded by the involved facility; however, an image was provided.From the provided image, it was confirmed that the purge line of oxygenator was fractured from the port.We have experienced that the similar fracture may have been occurred when momentary external force was applied while the product was cold.The local temperature from february 2023 to the date of occurrence ((b)(6) 2024) was investigated.It was found that the minimum temperature was below zero.The manufacturing record and the shipping inspection record of the actual sample found no anomaly.One similar report of the product with the involved product code/lot (ppr-23-1941-1) was found.In addition, no actual sample for ppr-23-1941-1 was also available.Based on the investigation result, no anomaly was found in the manufacturing records of actual product.As a possible cause of occurrence, based on our past experience, it was inferred that after the product was shipped from the factory, during the distribution process in the cold season, momentary force was applied to the product while it was cooled, causing it to fracture.However, since the condition of damage on the actual product could not be confirmed, it was not possible to identify the cause of this case.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.

• Brand Name: CAPIOX FX 15 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: 18777328
• Report Number: 9681834-2024-00020
• Device Sequence Number: 8307917
• Product Code: DTZ
• UDI-Device Identifier: 04987350701121
• UDI-Public: 04987350701121
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• 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): 02/26/2024

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: 11/30/2025
• Device Model Number: N/A
• Device Catalogue Number: CX*FX15RW40
• Device Lot Number: 221215
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2024
• Initial Report FDA Received Date: 02/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2022
• 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