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

Catalog Number CX-FX25REV

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 02/01/2022

Event Type  malfunction  

Event Description

The user facility reported that during priming of the capiox device they found that the sampling system dislodged, so they stopped using it and replaced it with a new one immediately.The procedure outcome was not reported.There was no harm to the patient.

Manufacturer Narrative

Udi - not required for product code.Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation- clinical engineer.Pma/510k # - k130280.The actual sample was not available for investigation.Since the actual sample was not returned to ashitaka factory, the investigation of it was unable to be performed.However, the image of the actual sample showed that the sampling system had been detached from the mount.Review of the manufacturing record and the product-release judgment record of the involved product/lot# combination confirmed that there were not any anomalies in them.A search of the complaint file found no other similar report with the involved product code/lot# combination.Ifu states: "do not use if the package or device is damaged (e.G.Cracked) or any of the port caps are off." based on the investigation and our experience, as a possible cause of occurrence, it was inferred that they attempted to detach the mount from the reservoir in a way grabbing the sampling system only.Since the actual sample was not returned for analysis, the cause of occurrence could not be clarified.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 FX OXYGENATOR
• 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: stephanie handy ; reg. no. 2243441; 950 elkton blvd.; elkton, MD 21921 ; 9499890491
• MDR Report Key: 13635790
• MDR Text Key: 287271995
• Report Number: 9681834-2022-00019
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CX-FX25REV
• Device Lot Number: 210729
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2021
• 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