MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX RX25; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number N/A

Device Problem Break (1069)

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

Event Date 02/13/2023

Event Type  malfunction  

Event Description

The user facility reported that the junction between the oxygenator and reservior was broken.The procedure outcome was not reported.The patient was not harmed.

Manufacturer Narrative

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.The actual device has not been received yet for evaluation.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.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).

Manufacturer Narrative

This report is being submitted as follow-up no.1 to update the sample availability in section d9, to update section h3, and to provide the completed investigation results.Confirmation of the provided image: the fitting between the oxygenator and the support arm was disconnected.Simulation test in ashitaka factory: free-fall test of the product in a unit box was performed.It was found that the oxygenator was disconnected from the support arm.Record review: the manufacturing record and the shipping inspection record of the actual sample · 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 simulation test result, it was inferred that since some strong impact load exceeding the limit strength was applied during the distribution process and storage, the event occurred.However, it was not possible to confirm the actual sample, and the cause of occurrence could not be clarified.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 RX25
• Type of Device: 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 ; 6402040886
• MDR Report Key: 16537815
• MDR Text Key: 311393301
• Report Number: 9681834-2023-00045
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350769572
• UDI-Public: 04987350769572
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K040210
• 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,Followup
• Report Date: 03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CX*RX25RW
• Device Lot Number: 220401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2022
• 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: 54 YR
• Patient Sex: Male