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

Catalog Number CX*FX05RW

Device Problem Pumping Problem (3016)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/15/2018

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.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.(b)(4).

Event Description

The user facility reported air bubbling on the involved capiox device during cardiopulmonary bypass approximately at 10:01 am.The baby-fx oxygenator with integrated arterial filter that "after being on bypass for five minutes cardioplegia line was flushed to field.After shutting off plegia arterial bubble detector went off shutting down pump flow to patient.The surgeon was notified and the arterial line clamped at field.The venous and arterial lines at the pump were clamped.Two small air bubbles were noted distal to air detector.No other air noted in line or circuit.The arterial line was flushed to side port of arterial cannula while clamped off to patient.The side port closed arterial line inspected from pump to patient then patient to pump.Bypass resumed after approximately one minute of no flow." the product was not changed out.Surgery was completed successfully.The event did result in a delay in the procedure.It was reported that there was no blood loss.There was no impact to the patient.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide the udi no., the expiration date, device return date, and the completed investigation results.The actual device was returned for evaluation.Visual inspection upon receipt revealed no defects.The actual sample, after having been rinsed, was built into a circuit with tubes and primed with colored saline solution in accordance with the ifu for this product.There was no air remaining inside the actual sample.The blood phase was filled with saline solution.With the blood outlet port clamped, air pressure was applied to the blood phase from the blood inlet port.No leak was confirmed.The actual sample was then circulated with bovine blood at the back pressure of 200mmhg and at each blood flow rate of 0.5l/min., 1.0l/min., and 1.5l/min.During circulation at each flow rate, an air of 10ml was sent into the circulation in 30 seconds.No air came through the filter out of the oxygenator module.Functional testing was conducted.A tube was connected to the luer port on the oxygenator module of the actual sample and the pump on the cardioplegia side was let to run.It was found that air was pulled into the oxygenator module when the flow rate of the blood going into the oxygenator module was lower than that going out of the oxygenator module, or when the pump on the extracorporeal circulation side was not running.There is no evidence that this event was related to a device defect or malfunction.The investigation result verified that the actual sample was the normal product without any leak which could lead air to enter the oxygenator module, having the normal air removal performance.As a possible cause of this complaint, the circulation of the line on the cardioplegia side may have led the pressure inside the oxygenator module to be negative and air may have been pulled into the oxygenation module through the fibers.However, the exact cause of the reported event cannot be definitively determined based on the available information.A review of the manufacturing record and the product release decision control sheet of the involved product/lot# combination confirmed there were no indications of production-related anomalies or discrepancies in the inspection results.A search of the complaint file did not find any other report of this nature with the involved product/lot# combination.The ifu states: to prevent gaseous emboli from entering the blood phase, make sure that the arterial pump flow rate always exceeds the flow rate of the cardioplegia line.The blood flow rate of the cardioplegia line should not exceed 0.5 l/min.

• 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, shizuoka 418 ; JA 418
• MDR Report Key: 7471930
• MDR Text Key: 106867491
• Report Number: 9681834-2018-00050
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K071572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: CX*FX05RW
• Device Lot Number: 171115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1