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

Catalog Number CX*FX05RE

Device Problem Infusion or Flow Problem (2964)

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

Event Date 05/25/2022

Event Type  Injury  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Telephone number - requested, not provided.Occupation - chief perfusionist.Pma/510k # - k130280.The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.Review of the manufacturing record and the shipping inspection record of the actual product confirmed that there were not any indications of anomaly in them.A search of the complaint file found no other similar report with the involved product code/lot# combination.(b)(4).

Event Description

The user facility reported that first they did bypass for 75 min.Then the patient was smoothly off after the echo was done.Protemen was given to the patient at that time out all pump suckers was off.After a few minutes, the patient had some problem again, so they gave them heparin and initiated bypass the patient.Second time we found problem in oxygenator and the oxygenation did not occur and they replaced with new one.The procedure was completed successfully.There was no harm to the patient.

Manufacturer Narrative

The actual sample was not returned to ashitaka factory, therefore an evaluation of the actual sample could not be performed.The provided photos and video of the actual product were confirmed.Any anomaly such as breakage that could lead to gas transfer failure could not be read from the photos.Review of the manufacturing record and the shipping inspection record of the actual product confirmed that there was not any anomaly in them.A search of the complaint file found no other similar report with the involved product code/lot# combination from other facilities.Based on the investigation result, any anomaly such as breakage that could lead to gas transfer failure could not be read from the provided photos, and also no anomaly was found in the manufacturing record.It was described in the reported issue that "the patient smoothly off after done echo and protamine given to the patient.After few minutes, patient got some problem again we gave the heparin and initiate the bypass the patient.Second time we found problem in oxygenator and the oxygenation not occur".Therefore, it was inferred that after neutralizing heparin with protamine, blood clots formed in the oxygenator, leading to gas transfer failure.However, since the actual product could not be confirmed, the cause of occurrence could not be clarified.Ifu states: "do not reduce heparin during circulation.Otherwise, blood clotting might occur.(warnings): adequate heparinization of the blood is required to prevent it from clotting in the system.(warnings)." terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.

• Brand Name: CAPIOX FX 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 ; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 14828303
• MDR Text Key: 295031123
• Report Number: 9681834-2022-00102
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350781758
• UDI-Public: 04987350781758
• Combination Product (y/n): N
• Reporter Country Code: PK
• PMA/PMN Number: K071572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: CX*FX05RE
• Device Lot Number: 200817
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2020
• 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 Outcome(s): Required Intervention
• Patient Weight: 11 KG