MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION ADVANCED PERFUSION SYSTEM 1; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS- ADVANCED PERFUSION SYSTEM 1

Model Number 802018

Device Problem No Device Output (1435)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

Per the perfusionist, the centrifugal pump was recirculating for approximately two hours with a visible flow reading on the ccu.Upon initiation of cpb, the perfusionist noticed the flow reading changed to dashes.She checked to see that the flow sensor was properly attached to the line and plugged into the ccu, and that the centrifugal pump was properly seated.The venous reservoir began to show a rising level of blood, indicating no forward flow.She clamped the lines and discontinued cpb.The ccu was powered off then back on and the cables were checked again to make sure they were secure which they were.After the ccu powered back up, the flow numbers were displayed again, and bypass was reinitiated with no further problems.The field service representative (fsr) could not verify the reported flow display issue.The flow monitoring system functioned properly when tested.He reseated the flow module and flow sensor connections.The unit operated to the manufacturer's specifications.

Event Description

It was reported that during a cardiopulmonary bypass (cpb) procedure, the flow reading on the centrifugal control unit (ccu) was displaying dashes.The surgical procedure was completed successfully.There was a delay of less than a couple of minutes.There was no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

Updated blocks: b1, b2, b5 and h6.

Event Description

Per clinical review: the manufacturer's clinical specialist spoke with the perfusionist regarding an issue the team had with their heart lung machine (hlm) during a cardiopulmonary bypass (cpb) procedure on (b)(6) 2020.The hlm was set up and primed without issue for the cpb procedure with visible flow reading on the centrifugal control unit (ccu).Upon initiation of cpb, the perfusionist noticed the flow reading changed to ---.The perfusionist checked to see that the flow sensor was attached line, open and closed it, pushed it down from the latch of the flow probe and unplugged and plugged it into the control unit.The team also checked that the centrifugal pump was properly seated.The perfusionist stated that the central control monitor (ccm) was working fine through that process.Because of the interaction with the actual disposable and the troubleshooting of the pieces, the venous reservoir began to show a rising level of blood (giving the indication that there was no forward flow).The perfusionist clamped the patient lines and discontinued cpb for a brief period of time.The cables leading to the back of the control unit were checked and were secure.After the control unit was powered back up (~ two seconds), flow numbers were displayed on the control unit and therefore, bypass was reinitiated with no further problems.There was no true delay in the continuation of the surgical procedure, but a slight delay in forward flow to the patient.There was no blood loss or harm and the patient did well.

Manufacturer Narrative

The reported complaint was not confirmed.Per data log analysis, on (b)(6) 2020 at 06:36:21 a perfusion screen was opened.At 06:44:47 the flow sensor was coupled to tubing with fluid.At 07:26:24 three backflow events occurred.At 14:14:44 the perfusion screen was exited.The central control monitor (ccm) was shutdown at 14:14:51, and powered back up at 17:19:34, the flow sensor was already coupled to tubing with fluid.At 17:19:53 a perfusion screen was opened.At 19:27:06 multiple backflow alarms occurred.There was no indication of a problem in the flow log.Normally flow will go to dashes if the sensor is not coupled properly, or there is not enough fluid in the tube but this would not have been logged.Cannot confirm the complaint from the logs.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

• Brand Name: ADVANCED PERFUSION SYSTEM 1
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS- ADVANCED PERFUSION SYSTEM 1
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• MDR Report Key: 11058571
• MDR Text Key: 223797127
• Report Number: 1828100-2020-00496
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K172220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 802018
• Device Catalogue Number: 802018
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: VENOUS RESERVOIR.
• Patient Outcome(s): Required Intervention