MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX RX25 OXYGENATOR/RESERVOIR; BLOOD GAS OXYGENATOR

Catalog Number CX*RX25RW

Device Problems Air Leak (1008); Pumping Stopped (1503)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/12/2015

Event Type  malfunction  

Manufacturer Narrative

This section was completed by the manufacturer per cfr 803.52 because the information was not initially completed by the user facility.Event problem codes for the patient as well as the device was left blank.Currently we are unable to input codes into these sections.For this reason the codes used and their descriptions are listed below.Notification of this issue has been sent to (b)(6).The actual device has not been received by the manufacturing facility for evaluation.A follow up report will be sent within 30 days of this report being sent.For this reason, evaluation code was used in the conclusions section.A review of the device history record and product release decision control sheet of the involved product/lot# combination confirmed that there were no production-related problems or discrepancy in the inspection/test results.A review of the complaint files confirmed the involved product code/lot# combination has not been reported previously.All available information has been placed on file in quality management for appropriate tracking, trending and follow up.(b)(4).Actual device not returned.

Event Description

The user facility reported air bubbling in the capiox rx25 device.Follow up communication with the user facility reported the following information: (1) the air bubbling occurred during priming; (2) after recirculation with crystalloid, the pump stopped, placing clamps in arterial and venous sides, closing all shunts, recirculation line and sampling lines; (3) after that, air-bubbles started arising from the bottom of the oxygenator; (4) the oxygenator was replaced with a new one; (5) the operation started and completed successfully.

Manufacturer Narrative

This report is being submitted as follow-up #1 for mfg.Report #9681834-2015-00135 as notification that the return sample evaluation is currently ongoing.Results will be provided once the evaluation is complete.A follow up report will be submitted when the investigation is complete, but no later than 30 days from the date that this report was sent.All currently available information has been placed on file by qa at the manufacturing facility for appropriate tracking, trending and follow-up.

Event Description

This report is being submitted as follow-up #1 for mfg.Report #9681834-2015-00135 to notify the fda that the return sample evaluation is currently ongoing.Results will be provided once the evaluation is complete.

Manufacturer Narrative

This report is being submitted as follow-up # 2 for mfg.Report # 9681834-2015-00135 to provide the return sample evaluation results.The actual sample was returned to the manufacturing facility for evaluation.Visual inspection of the actual sample upon receipt did not find any anomalies.The actual sample was filled with saline solution and subjected to a pressure of 2.0kgf/cm2.No leak was noted.The actual sample was built into a circuit with tubes and a centrifugal pump and was circulated with saline solution at the flow rate of 4.5l/min.And approx.2500 rpm /min with the centrifugal pump.No air entrainment was confirmed.Simulation testing was conducted on the actual sample.The actual sample was built into a circuit with tubes and a centrifugal pump and was circulated with saline solution at the flow rate of 4.5l/min.At approx.2500 rpm /min with the centrifugal pump, with no back pressure applied, the tube at the outlet of the centrifugal pump was full-clamped.Air entrainment was confirmed.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 investigation result verified that the actual sample did not have any anomaly which could lead to air entrainment into the oxygenator module.There is no evidence that this event was related to a device defect or malfunction.Although the exact cause cannot be determined, as a cause of air being entrained into the actual sample during priming, it is conceivable that the pressure inside the oxygenator module turned to be negative and air was pulled inside the oxygenator through the fibers.As a cause of the generation of a negative pressure in the oxygenator module, there may have been a clamping of the tube with forceps.A clamping manipulation leads the inflow of the priming solution into the inside of the oxygenator module to stop, and at the same time, the priming solution staying inside the oxygenator module flows out inertial, where a negative pressure is generated due to the difference between the volume of the inflow and outflow of the priming solution.During the simulation test where the actual sample was circulated at the flow rate around 4 and 5l/min, which was the maximum flow rate during priming, air entrainment into the actual oxygenator module was not duplicated.The labeling does address the potential for such an event in the instructions-for-use with statements such as the following: "when using the centrifugal pump on the arterial line, clamp the arterial line distal to the oxygenator (the patient's side) before stopping the pump.Improper clamping may cause back-flow of blood or migration of gaseous emboli into the blood side." all currently available information has been placed on file by qa at the manufacturing facility for appropriate tracking, trending, and follow-up.(b)(4).

Event Description

This report is being submitted as follow-up # 2 for mfg.Report # 9681834-2015-00135 to provide the return sample evaluation results.

• Brand Name: CAPIOX RX25 OXYGENATOR/RESERVOIR
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer Contact: kathleen little ; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 4913104
• MDR Text Key: 22388444
• Report Number: 9681834-2015-00135
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K040210
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Report Date: 06/22/2015,07/14/2015

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 Expiration Date: 01/31/2018
• Device Catalogue Number: CX*RX25RW
• Device Lot Number: 150224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2015
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 06/12/2015
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/22/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2015
• 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