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

Catalog Number CX*FX25RW

Device Problem Break (1069)

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

Event Date 02/18/2022

Event Type  malfunction  

Event Description

The user facility reported that during pre-treatment; during set up of the capiox device, the user noticed that the connector is lose and they noticed it is broken/chipped so they decided to not use this item and change.The procedure outcome was not reported.The patient was not harmed.

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Health professional - requested, not provided.Occupation - requested, not provided.Pma/510(k)- k130520.A review of the manufacturing record and the product release judgement record of the involved product code/lot# combination confirmed there were no indications of anomaly in them.A search of the complaint file found no other similar report with the involved product/lot# combination.The actual device was discarded by the user facility.An image provided by the user showed that the flange of l-connector of the actual sample had been chipped.Simulation test: a female l-connector was connected to a factory-retained sampling system, and then exposed to a tensile load.As a result, the flange of the female l-connector was chipped.Based on our experience, it was likely that the l-connector was exposed to a tensile load at some point during the period between the assembly process in our factory and actual use by the customer, which resulted in the chip in the flange.However, since the actual sample was not available for analysis, the cause of occurrence could not be clarified.Ifu states: "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: 13825109
• MDR Text Key: 287898397
• Report Number: 9681834-2022-00029
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350701046
• UDI-Public: 04987350701046
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 03/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CX*FX25RW
• Device Lot Number: 210908
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/21/2022
• Initial Date FDA Received: 03/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2021
• 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