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

Model Number N/A

Device Problem Pressure Problem (3012)

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

Event Date 11/16/2022

Event Type  malfunction  

Manufacturer Narrative

Patient identifier: requested, not provided.Age: requested, not provided.Ethnicity: requested, not provided.Race: requested, not provided.Implanted date: device was not implanted.Explanted date: device was not explanted.Initial reporter name: unknown.Phone number: unknown.Health professional: unknown.Occupation: unknown.Pma/510(k) #: k130520.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.The manufacturing record and the shipping inspection record of the actual product found no anomaly.No other similar report was found with the product of the involved product code/lot number.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 high pressure with the oxygenator involved.High delta p during the procedure.The oxygenator was not exchanged due to the progress of the procedure.The procedure could be finished with the complained oxygenator.The event occurred intra-operative.There was no patient injury/medical or surgical intervention required.There was no harm to the patient.

Manufacturer Narrative

H6: investigation conclusions: code 4310 is based upon the investigation of the provided information; code 67 is based upon investigation of the returned sample.This report is being submitted as follow up no.1 to provide the device return date in section d9, update section h3, and to provide the completed investigation results.Visual inspection of the actual sample upon receipt found no anomaly such as a breakage was found.After rinsing and drying the actual sample, the oxygenator was installed into a circuit consisting of tubes, and bovine blood (hct: 35%, temp.: 37°c) was circulated with a flow rate of 8.0 l/min.Then, the pressure drop was measured.It was confirmed to meet the factory's specifications and no obstruction was found.After circulation of bovine blood, saline solution was flowed in the blood channel.No blood clot that led to the obstruction was formed.The contents of pump record were confirmed.However, it was not possible to read the cause of the increase in pressure drop.Review of the manufacturing record and the shipping inspection record of the actual sample confirmed that there was not any anomaly in them.A search of the complaint file found no other similar report of the product with the involved product code/lot number combination.Based on the investigation result, no anomaly was found in the actual sample after rinsing.As a cause of occurrence, it was likely that blood-derived obstruction occurred for some reason.However, since no anomaly was found in the performance test of actual sample, it was not possible to clarify the cause of this complaint from the investigation result.Relevant ifu reference: "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)".

• 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: gina digioia ; reg. no. 2243441; 950 elkton blvd.; elkton, MD 21921 ; 6402040886
• MDR Report Key: 15987052
• MDR Text Key: 308283843
• Report Number: 9681834-2022-00252
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350701060
• UDI-Public: 04987350701060
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CX*FX25E
• Device Lot Number: 220517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2022
• 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 Sex: Male
• Patient Weight: 153 KG