MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number N/A

Device Problems Break (1069); Increase in Pressure (1491)

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

Event Date 10/26/2022

Event Type  Injury  

Event Description

The user facility reported that when the caipox device oxygenation, was high pressured.Overpressure of the oxygenator was hypothesized with a possible breakage of oxygenating fiber that has determined gaseous embolism along the arterial line of the cec circuit.There were no consequences and was a regular post operative course.The problem occurred during a cardio bypass before x-clamps.The event resulted in a 20-minute delay.The product was changed out, capiox fx05.No consequences for the patient.As a result of the reported issue 380ml of blood was lost.Flow was 650ml/minutes and pressure out were 600mmhg.The event occurred intra-operative.The device malfunction due to increasing pressure.The procedure outcome was completed successfully.The final patient impact was not harmed.

Manufacturer Narrative

Patient ethnicity: requested, not provided.Patient race: requested, not provided.Implanted date: device was not implanted.Explanted date: device was not explanted.Initial reporter health professional: requested, unknown.Initial reporter occupation: vigilance responsible.Pma/510(k): k071572, 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 shipping inspection record of the actual sample found no anomaly in them.A search of the complaint file found no similar indications regarding the involved product code/lot number combination.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).

Manufacturer Narrative

This report is being submitted as follow-up no.1 to provide the device return date in section d9, to update section h3, and to provide the completed investigation results.The actual device has been returned for evaluation.Visual inspection of the actual sample upon receipt revealed that no anomaly such as a brakeage 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 1.5 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.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 instructions for use (ifu) reference: the end of the report 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 HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER
• 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: 15921016
• MDR Text Key: 304871917
• Report Number: 9681834-2022-00241
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350781772
• UDI-Public: 04987350781772
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K071572
• 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: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CX*FX05RW
• Device Lot Number: 211220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 2 YR
• Patient Sex: Female
• Patient Weight: 9 KG