MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION CAPIOX RX25 OXYGENATOR EAST; BLOOD GAS OXYGENATOR

Model Number 3CX*RX25RE

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 10/10/2017

Event Type  malfunction  

Manufacturer Narrative

Terumo has received the device for evaluation; however, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is complete and when more information becomes available.(b)(4).

Event Description

The user facility reported to terumo cardiovascular that during prime, there were air bubbles out through the arterial outlet, this coincided with the closure of the larger recirculation.No patient involvement.Product was changed out.Delay was unknown.Procedure was completed successfully.

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on october 27, 2017.The returned sample was visually inspected.A scratch was found on the blood outlet port.No other anomaly was noted on the reminder of the device.The investigation result verified that the actual sample was the normal product with no anomaly related to air entrainment.It is assumable, as a cause of this complaint, that abrupt decrease in the flow rate generated by clamping the circulation led the pressure inside the actual oxygenator to be negative, resulting in air entrainment into the oxygenator.As a cause of the pressure inside the oxygenator having been negative, it is likely that the flow of the prime into the oxygenator was cut off due to the application of clamping while the prime inside the oxygenator was still flowing out of the oxygenator by inertial force.From the available information, however, it is difficult to determine the cause of this complaint definitely.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: CAPIOX RX25 OXYGENATOR EAST
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• Manufacturer Contact: cathleen hargreaves ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 6985288
• MDR Text Key: 91188236
• Report Number: 1124841-2017-00226
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: 3CX*RX25RE
• Device Catalogue Number: N/A
• Device Lot Number: VD27
• Other Device ID Number: (01)00699753450103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2017
• 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