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

Model Number 801041

Device Problems Pumping Stopped (1503); Output Problem (3005)

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

Event Date 11/18/2020

Event Type  malfunction  

Manufacturer Narrative

Per the manufacturer sales representative, the perfusionist stated the hlm nor the roller pump provided any alerts.The perfusionist was only alerted by the dms when it gave a compliance alert that the pressure had dropped to zero.When she looked at the pump she noticed that the roller was not working and the screen was blank except for the 'service pump' message in the upper left hand corner.After the case, the pump was removed from the base and replaced with a back-up.The field service representative (fsr) replaced the roller pump head and performed all verification checks.The unit operated to the manufacturer's specifications.The suspect device was returned to the manufacturer for further evaluation.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the pump for the arterial line stopped and displayed a 'service pump' message.The perfusionist powered the roller pump off and then back on again.It was used for the remainder of the case without any issues.The surgical procedure was completed successfully.There was a 30 second delay, no blood loss, nor adverse consequences to the patient.Per clinical review: during a cpb procedure on 18nov2020, the team had an arterial roller pump on a heart lung machine (hlm) stop and give the perfusionist a 'service pump' message.The perfusionist set up and primed the circuit without issue from the roller pump for a case on (b)(6) 2020.About half way through the procedure, the data management system (dms) in use gave a notice of no arterial flow.She then proceeded to scan the hlm and noticed that the arterial roller pump had a 'service pump' message.She was able to cycle the power and activate the pump and come back to normal flow without issue.The pump had no other failures or error messages for the remainder of the procedure.There was a delay of forward flow to the patient, quoted at about 30 seconds.There was no stated harm or blood loss due to this occurrence.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) did not observe any issues with the roller pump.The roller pump ran continuously for approximately 21 hours with a lab use only (luo) water loop and no errors were logged.The roller pump was opened and no anomalies were noted.Per data log analysis, on (b)(6)2020 the following was noted: 06:16:02 a perfusion screen is opened.06:39:42 the large roller pump is started.06:52:56 a low level alarm stops the pump.06:54:20 the pump is started.07:11:06 the pump stops (possible service pump error).07:11:08 the pump started.07:11:26 the pump stops (possible service pump error).09:09:29 the pump started.09:22:40 the pump stops (possible service pump error).09:40:47 the pump started.10:44:43 the pump stops (likely service pump error).10:44:49 the pump started.The pump was stopped four times in the log because the start/stop button was pressed or an un-logged error occurred.The un-logged error could be that the pump was detected running in reverse incorrectly which would stop the pump and display a 'service pump' message on the local display.There is no way to confirm from the logs what actually happened since that event was not logged.

Manufacturer Narrative

The reported complaint was confirmed.The roller pump has reached its end of service life so no additional servicing activities were done.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: 10992854
• MDR Text Key: 220981300
• Report Number: 1828100-2020-00477
• 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: 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 801041
• Device Catalogue Number: 801041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1