MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION CAPIOX FX 15 HOLLOW FIBER OXYGENATOR AF; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	N/A
Medical Device Problem Codes	Break (1069); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1: patient identifier: no patient involvement.A2: age or date of birth: no patient involvement.A3a: sex: no patient involvement.A3b: gender: no patient involvement.A4: weight: no patient involvement.A5: ethnicity: no patient involvement.A6: race: no patient involvement.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E2: health professional: requested, unknown.E3: occupation: requested, unknown.G4: 510(k) no: k071494, k130520.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.Confirmation of the provided image found that the purge line of oxygenator was fractured from the port.We have past experienced that 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 (january 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.Past complaint file found no other similar report of the product with the involved product code/lot# was found.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.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.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 scientific research institute reported that the involved capiox device oxygenator was broken.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.This could not be occurred during transportation (no visible signs) or removing oxygenator from the box.The hospital is active user of capiox fx oxygenators and handles them with care, so an intentional damage is excluded.The event occurred pre-treatment.There was no patient involvement.

• 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: 18813577
• Report Number: 9681834-2024-00021
• Device Sequence Number: 19913377
• 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): 02/29/2024

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: 02/29/2024
• 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