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

Model Number 3CX*RX25RW

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Patient Involvement (2645)

Event Date 03/27/2018

Event Type  malfunction  

Manufacturer Narrative

Terumo has not received the device for evaluation; therefore, 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 prior to cardiopulmonary bypass, during prime, the air got sucked in the arterial line, resulting a difficulty in de-airing.There was no patient involvement as this occurred during prime.Product was changed out.It is unknown if there was a delay in the procedure, or if the surgery was completed successfully.

Event Description

Additional information was received from the user facility there was no delay in the procedure.The 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 may 04, 2017.  (b)(4).A second follow-up will be submitted upon completion of the investigation and/or submission of new information.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations.(b)(4).The sample was not returned for evaluation, therefore a thorough investigation could not be performed and definitive root cause cannot be determined for this event.A retention sample was set into a circuit and primed.There was no difficulty in priming the oxygenator and no air entrainment was observed.Previous laboratory testing has identified that an abrupt decrease in the flow rate can cause air to be pulled into the oxygenator.This can be generated by clamping circulation leading to pressure inside the oxygenator becoming negative, resulting in air entrainment into the oxygenator.It is likely that the flow of the prime into the oxygenator was cut off due to an application of clamping while the prime inside the oxygenator was still flowing out of the oxygenator by inertial force.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: CAPIOX RX25 OXYGENATOR WEST
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 7978559
• MDR Text Key: 124134461
• Report Number: 1124841-2018-00260
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450110
• UDI-Public: (01)00699753450110
• Combination Product (y/n): N
• PMA/PMN Number: K153213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: 3CX*RX25RW
• Device Catalogue Number: N/A
• Device Lot Number: WA08N
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1