MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SARNS 8000 MODULAR PERFUSION SYSTEM; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-SARNS 8000 PERFUSION SYSTEM

Model Number 6379

Device Problem Backflow (1064)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/31/2018

Event Type  malfunction  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, there was an error message on the central control monitor (ccm).As a result, an alternate device was employed.The surgical procedure was completed successfully.There was a one minute delay, no blood loss, nor adverse consequences to the patient.Per clinical review: the procedure on (b)(6) 2018 was an off pump coronary artery bypass surgery (opcab) that the patient needed to be emergently placed on cpb.The perfusionist needed to prime the system quickly to place the patient on cpb.The system primed up without issue.The perfusionist proceeded to hand up the lines and the team clamped them immediately before he was able to clamp them on his end.The perfusionist heard an alarm, which he stated could have been a retrograde flow alarm and he noticed that his flow reading was jumping around from 0.00 to higher numbers and back down.He next turned his revolutions per minute (rpms) to zero, and checked the clamps on his end to ensure that all clamps were appropriately placed on his circuit.The perfusionist then cycled the power on the pump and the system was still alarming.He then proceeded to disconnect the flow probe and the alarm stopped.He retrieved a flow probe from another pump and attached it to the console.The system did not alarm, therefore he initiated cpb.He did not recall his rpms on the system at the time of initiation, but backflow was occurring.The perfusionist chose to quickly clamp the arterial and venous lines, and exchange the pump on the base of the heart-lung machine (hlm) with the backup pump.He placed the flow meter back on the console, placed the disposable pump head on the drive motor and was able to come up on the rpms and re-initiate appropriate forward flow to the patient.The patient was without forward flow for approximately a minute while the perfusionist was exchanging consoles.The perfusionist stated that anesthesia was able to ventilate the patient, and that the cerebral oximetry values went from the mid 70's to the mid 50's.He said that the patient was following commands and had a normal course of recovery.The perfusionist stated that he might have accidentally pressed a button on the front of the pump when he pushed the hlm to the field in an urgent manner, but he did not recall that being the case.There was no blood loss or harm associated with the procedure.

Manufacturer Narrative

The reported complaint was confirmed.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Manufacturer Narrative

The field service representative (fsr) was unable to verify the reported complaint.He installed a test loop and ran for several minutes without any errors.The unit operated to the manufacturer's specifications.

• Brand Name: SARNS 8000 MODULAR PERFUSION SYSTEM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-SARNS 8000 PERFUSION SYSTEM
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• MDR Report Key: 8094088
• MDR Text Key: 128434136
• Report Number: 1828100-2018-00599
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K915183
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6379
• Device Catalogue Number: 6379
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention