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 06/02/2021

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.The actual sample was received for evaluation.Visual inspection with unaided eye revealed that the tube had been connected to the venous blood port of the reservoir and fixed with a tie-band by the user.Visual inspection of the tube after detached from the venous blood port of the reservoir found it had been fractured at the joint with the venous blood port.The fracture surface of the tube was inspected under a magnification and electron microscope.It was found smooth, which inferred that the fracture 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 fracture.The 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.Simulation test/low-temperature fragility: it is known from experience that a fracture of tube similar to that observed on the actual sample may occur when the product in a low-temperature condition is subjected to a momentaneous shock load.A test sample was chilled and then fractured by having been exposed to a momentaneous shock load.Electron microscopic inspection of the fracture surface was found to be similar to that of the actual sample.The above test condition was set discretionary.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 sates: 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 was likely that the product cooled down due to low temperature in the transportation or the storage during the cold season might have been subjected to some kind of strong impact load during being handled, which resulted in the fracture.However, the exact timing at which the fracture occurred could not be clarified.The exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).

Event Description

The user facility reported that the capiox device was used pre-treatment.There was leakage; the sampling line tube fractured at the joint with blood inlet port of reservoir.The operator tried to remedy this by adding plastic cable tie, however failed.The patient was not harmed.The procedure outcome was not reported.

• 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: 12090913
• MDR Text Key: 260722977
• Report Number: 9681834-2021-00111
• 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,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: CX*RX25RW
• Device Lot Number: 201030C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2020
• 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