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

Catalog Number CX*RX25RW

Device Problems Leak/Splash (1354); Material Separation (1562)

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

Event Date 03/17/2021

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted, explanted date: device was not explanted, address-(b)(6).The actual sample and a video were provided by the user facility.Review of the video confirmed that liquid was leaking from the sampling line.Visual inspection with unaided eye revealed that the sampling line tube had been fractured and separated from the connection with the oxygenator port.Magnifying and electron microscopic inspections of the sampling line tube found that the fracture surface was smooth, which inferred that the fracture may have developed rapidly by having been exposed to a momentaneous shock load.There was not any foreign substances or air embedded in the material, which could be a trigger of the fracture.The sampling line tube was cut, and the cross-section was inspected under magnification.There was no unevenness in the wall thickness.The outside and inside diameters of the tube were measured.Compared to the current product sample, no difference was confirmed in the measured values.Reproductive test/low-temperature fragility: presuming that the fracture occurred during transportation, multiple test samples packed in the unit boxes were cooled, and then dropped from 1.5 meter high.As a result, some of the sampling line tubes were fractured at the joint with the product.Multiple test samples, after having been cooled, were exposed to momentaneous shock load.As a result, some of the sampling line tubes were fractured.The fracture surface was similar to that observed on the actual sample (the test conditions were set arbitrarily).A review of the device history record and the product-release judgement record of the involved product code/lot# combination was conducted with no findings.Ifu states: if the product is dropped during set-up, do not use it.Replace with another device.Do not use if the package or device is damaged (e.G.Cracked) or any of the port caps are off.Do not use an oxygenator and reservoir that leaks.Replace it with another capiox fx25 oxygenator and reservoir.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 sampling line tube of the actual sample had been broken partially at the joint with the oxygenator port.As a possible cause of occurrence, based on the state of the fracture surface of the actual sample and the reproductive test result, it was presumed that the fracture occurred in the sampling line tube due to the following mechanism.While the actual sample was being handled in a low temperature condition due to the transportation or storage in the cold season, a momentaneous shock load was applied to the actual sample causing the fracture on the sampling tube.However, the exact cause of the reported event cannot be definitively determined based on the available information.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 that the involved capiox device was used pre-treatment and there was leakage.During priming, the perfusionist found the sampling line tube fractured at the joint with blood outlet of oxygenator.Procedure outcome was not reported.The patient was not harmed.

• Brand Name: CAPIOX RX25 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: mary o'neill ; reg. no. 2243441; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 11626323
• MDR Text Key: 261951752
• Report Number: 9681834-2021-00050
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: CX*RX25RW
• Device Lot Number: 200720C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2020
• 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: 56 YR
• Patient Weight: 56