MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX15REC W/ 4L RES; BLOOD GAS OXYGENATOR

Model Number 3CX*FX15RE40C

Device Problem Pumping Problem (3016)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/15/2016

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 during cardiopulmonary bypass, there was air in the arterial line.The surgeon harvested the lima, opened the pericardium, did the sutures for the cannula.The hlm was running at low flows throughout.The lines were taken onto the table and the flows were increase as requested by the surgeon.During this time all of the safety features of the hlm were turned on and checked as per pre bypass check list.This included the level sensors as well as the air detector.The hlm had been circulating without any air being detected or any other unusual incident for over an hour.The arterial cannula was inserted and once snugged and de-aired, the surgeon asked for the pump to move the fluid up the line so that the lines could be further de-aired prior to connection.The lines were connected and opened to the hlm.The swing and pressure were checked and the surgeon was advised that there was good swing in the bubble isolator and that the pressure was matching that of the monitor.The other cannulae were inserted and the surgeon asked to go on bypass once the act was acceptable.Once the act reached 400 the surgeon was notified that bypass was started.As the minimum safe level was in the venous reservoir, the venous line was slightly opened to obtain a small amount of volume.The arterial pump was started and the gas turned on.Less than 30 seconds later, the arterial pump stopped and the warning (arterial air) was displayed on the screen.The arterial pump stopped and the venous line was not occluded immediately.This led to the patient volume being drained into the venous reservoir.The surgeon was notified that the patient would have to come off bypass as there was air in the arterial line.Another perfusionist placed clamps on both the arterial and venous line and the surgeon clamped the arterial line nearer the patient.Air was visible between the oxygenator and the air detector and the surgeon advised that there were air bubbles on the hlm side of the clamp he had placed on the arterial line.The patient's blood volume was decreased due to the venous drainage.The blood in the venous reservoir was returned to the patient via the venous line.Once the patient was stable, the hlm circuit was disconnected from the cannulae and joined together with a connector.Circulation started around the hlm to remove any air in the circuit, however the air detector once again detected air and stopped the arterial pump again.The air detector was switched off and blood circulated around the lines to remove any remaining air.It was determined that another hlm should be primed and brought in to replace the existing one.A new pump was brought in and patient went on bypass without incident.The volume from the previous pump was added to the new pump and a haemofilter set up so that the excess fluid could be filtered off to reduce haemodilution of the patient.The surgeon stated that he did not think any air had reached the patient.No known impact or consequence to patient.Product was changed out.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 july 15, 2016.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

The sample was returned for evaluation.The returned sample was visually inspected, during which no anomalies were noted.A review of the device history record revealed no anomalies.The returned oxygenator, including the purge line and the connected arterial sampling line, were all leak tested together by pressuring the unit and lines to approximately 600 mmhg with water.The sample was observed for leaks while pressurized.No leaks were found.The event could not be replicated and root cause could not be determined; therefore, this complaint is not confirmed.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: STERILE FX15REC W/ 4L RES
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball rd; elkton MD 21921
• Manufacturer Contact: shari bailey ; 125 blue ball rd; elkton, MD 21921 ; 8002837866
• MDR Report Key: 5798195
• MDR Text Key: 49660339
• Report Number: 1124841-2016-00276
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: 3CX*FX15RE40C
• Device Catalogue Number: N/A
• Device Lot Number: TP14
• Other Device ID Number: (01)00699753450813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2015
• 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