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

Model Number N/A

Device Problem Break (1069)

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

Event Date 04/26/2022

Event Type  malfunction  

Event Description

The user facility reported that when opening the capiox fx25 device external package two oxygenators were found with a broken purge line port and disconnected purge line at place of connection with oxygenator body.This could not be occurred during transportation (no signs) or removing oxygenator from the box.The defects were identified through the transparent package.This event occurred pre-treatment.The patient was not injured during the event and medical or surgical intervention was not required to prevent injury.The patient was not harmed.

Manufacturer Narrative

Implanted date: device was not implanted, explanted date: device was not explanted, occupation - other, pma/510(k)- k071494, k130520.The actual device was not returned for evaluation.Review of he provided image confirmed that the purge line of the oxygenator had been fractured at the connection with the oxygenator port.It is known from our experience that a fracture 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.Based on this, the temperature in the involved site for the past one year from the date of occurrence (b)(6) 2022 was checked and confirmed that the lowest temperature was below freezing.Assuming that the fracture occurred during transportation or storage, multiple test samples packed in 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 test condition was set discretionarily.Review of the manufacturing record and the product-release judgement record of the involved product/lot number combination confirmed there was no indication of anomaly in them.A search of the complaint file found no similar report with the involved product code/lot number combination.Based on the results of the investigation and the description of the complaint that the fracture was found upon opening of the box, it was presumed that the actual sample, which was in a cooled state due to the air temperature during transportation or the storage condition in the cold season, was subjected to a strong shock load when handled, leading to the fracture of the tube.However, since the actual sample was not available for analysis, the definite cause of occurrence could not be determined.Relevant ifu (instructions for use) reference: if the product is dropped during set-up, do not use it.Replace with another device.(a.Set-up, caution).(b)(4).

• 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
• 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: 14444734
• MDR Text Key: 293106055
• Report Number: 9681834-2022-00082
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350701046
• UDI-Public: 04987350701046
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: K071494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: N/A
• Device Catalogue Number: CX*FX25RW
• Device Lot Number: 201207
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2021
• 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