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

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that blood slowly drips from the gas outlet during cpb, the entire cpb procedure takes about one hour with a total of seven to eight drops.The procedure outcome was not reported.The patient was not harmed.
Additional Manufacturer Narrative
Patient identifier: requested, unknown.Date of birth: requested, unknown.Patient sex: requested, unknown.Weight: requested, unknown.Ethnicity: requested, unknown.Race: requested, unknown.Implanted date: device was not implanted.Explanted date: device was not explanted.Address: requested, unknown.Zip code: requested, unknown.Telephone number: requested, unknown.Pma/510(k): k130493.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.Record review: provided image: it was found that blood was adhered to the gas outlet port of oxygenator.However, it was not possible to identify the location of leakage from the image.The manufacturing record and the shipping inspection record of the actual product: no anomaly was found.Past complaint file: 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 record of the actual product.Since the actual sample could not be investigated, the cause of occurrence could not be clarified.Ifu states: : "do not use an oxygenator and reservoir that leaks.Replace it with another capiox rx05 oxygenator and reservoir." 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).

• 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 ; 6402040886
• MDR Report Key: 17015367
• Report Number: 9681834-2023-00106
• Device Sequence Number: 7555173
• Product Code: DTZ
• UDI-Device Identifier: 04987350763471
• UDI-Public: 04987350763471
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K022115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/26/2023

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: 04/30/2025
• Device Model Number: N/A
• Device Catalogue Number: CX*RX05RW
• Device Lot Number: 220510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2023
• Initial Report FDA Received Date: 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2022
• 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