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 Problems Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 09/22/2020

Event Type  malfunction  

Manufacturer Narrative

Per the manufacturer's sales associate, the flow module was unplugged from the back of the pump and plugged back in.The flow probe was then replaced and seemed to work correctly.The field service representative (fsr) could not verify the flow staying at zero.The fsr replaced the flow module and flow sensor.The unit operated to the manufacturer's specifications.

Event Description

It was reported that the roller pump flow was only showing zeros.No other details regarding the nature of this event were provided.

Event Description

Per clinical review: the manufacturer's clinical specialist reached out to the perfusionist numerous times to get more information.Not additional information was given.The information know is that during a cardiopulmonary bypass (cpb) procedure on (b)(6) 2020, the flow probe on the system was reading only zeros.The perfusionist proceeded to exchange the flow probe with another one and the reading was appropriate.There was no delay in the continuation of the surgical procedure.There was no harm or blood loss due to the incident.

Manufacturer Narrative

The reported complaint was not confirmed.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Event Description

Additional information was received that the issue occurred during use of the device for a cardiopulmonary bypass (cpb) procedure.

Manufacturer Narrative

Updated blocks: b5 and d10.During laboratory analysis, the product surveillance technician was unable to duplicate the reported complaint.When the flow sensor was connected to a water loop and a lab use only heart lung machine the flow was displayed accurately on the central control monitor.There were no issues throughout the evaluation.Per data log analysis, the flow issue was reported to happen on (b)(6) 2020.The system was left powered on so the system log was flushed, it only goes back to (b)(6) 2020.The flow log showed a couple backflow alarms and when they cleared, flow was at 0.The flow sensor was uncoupled once but that should cause flow to be displayed as dashes, not 0.There is no real indication of a problem in the log for the reported flow issue.

• 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: 10678868
• MDR Text Key: 211456144
• Report Number: 1828100-2020-00388
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 00886799000687
• UDI-Public: (01)00886799000687(11)200108
• 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: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 802018
• Device Catalogue Number: 802018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MEDTRONIC OXYGENATOR; MEDTRONIC PLATE