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

Model Number N/A

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/09/2024

Event Type  malfunction  

Manufacturer Narrative

A2: date of birth: 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.G4: pma/510(k): k130520.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.1.Confirmation of the provided image of the actual sample: it was confirmed that the water port (outlet side) of the oxygenator had been broken.It was not possible to confirm the condition of the broken area (to see whether there was elongation, molding defect, etc.) from the image.2.History investigation of the involved product code lot number: no anomaly was found in the manufacturing record and the shipping inspection record.No other similar event was found in the past complaint file.3.Manufacturing date: june 9, 2023.4.Cause of occurrence/conclusion: 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.Relevant 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.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.

Event Description

The user facility reported during routine inspections by the healthcare provider prior to the use of this oxygenator revealed the water outlet broken.The procedure outcome was not reported.The patient was not harmed.

• Brand Name: CAPIOX FX OXYGENATOR
• Type of Device: 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: 18660624
• MDR Text Key: 336077456
• Report Number: 9681834-2024-00003
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K071494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: N/A
• Device Catalogue Number: CX*FX25RW
• Device Lot Number: 230609
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 69 KG