MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX25 OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number CX*FX25RW

Device Problem Leak/Splash (1354)

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

Event Date 03/30/2021

Event Type  malfunction  

Manufacturer Narrative

Address: (b)(6) hospital.Pma/510(k): k130280.The actual device has been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.A review of the device history record and product-release judgement record of the involved product code/lot# combination was conducted with no findings.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).

Event Description

The user facility reported the capiox device was used pre-treatment.Leakage: the operator found liquid leak from the purge port during priming.The procedure outcome was not reported.The patient was not harmed.

Manufacturer Narrative

This report is being submitted as follow up no.1 to update section h3, and to provide the completed investigation results.The actual sample was received for evaluation.Visual inspection with the unaided eye confirmed that the purge line tube had been cracked and almost separated from the joint with the oxygenator port.The crack surface of the purge line tube was inspected under a magnification and electron microscope.It was found smooth, which inferred that the crack may have caused due to having been exposed to a momentaneous shock load.There was not any foreign substance or air embedded in the material, which could be a trigger of the breakage.The purge line tube of the actual sample was cut, and the cross-section was inspected under magnification.The wall thickness was confirmed even.The outside and inside diameters of the tube were measured.Compared to the current product sample, no difference in the measured values was confirmed.Reproductive test/low-temperature fragility testing was performed and assuming that the fracture occurred during transportation or storage, multiple test samples packed in the unit boxes were cooled, and then dropped from 1.5 meter high.As a result, some of the tubes were fractured at the joint with the product.The fracture surface of the fractured tube was evaluated and confirmed to be similar to that of the fractured purge line tube of the actual sample.The test condition was set discretionarily.Ifu states: if the product is dropped during set-up, do not use it.Replace with another device.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.It is likely that the product was chilled under low temperature environment during transportation or storage in the cold season, and the product in that chilled state was exposed to strong impact load during being handled, which resulted in the crack of the purge line tube.However, the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: CAPIOX FX25 OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 11670147
• MDR Text Key: 245535218
• Report Number: 9681834-2021-00063
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350701046
• UDI-Public: 04987350701046
• Combination Product (y/n): N
• PMA/PMN Number: K071494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: CX*FX25RW
• Device Lot Number: 200914C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2021
• Date Manufacturer Received: 04/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 84