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 Output Problem (3005)

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

Event Date 11/03/2020

Event Type  malfunction  

Manufacturer Narrative

The field service representative (fsr) verified the reported issue.A test loop was attached and the fsr was able to see the motor spinning and water flowing in the test loop, but there was no reading of measured flow on the ccm or the centrifugal control unit (ccu) display.The light emitting diode (led) on the suspected bad flow module never changed to red, it always remained green.The fsr used a flow module from another unit and was able to get flow reading on both the ccm and ccu.A new flow module was ordered.The suspect device was returned to the manufacturer for further evaluation.

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the central control monitor (ccm) displayed dashes for the flow.As a mitigation attempt, another flow sensor was used, but it did not correct the issue.As a result, an alternative device was used.No other details regarding the nature of this event were provided.

Event Description

Additional information was received that the surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

The reported complaint was confirmed.During laboratory analysis, the product surveillance technician duplicated the reported issue.The flow module was set up in a simulation loop and the issue reported as central control monitor (ccm) displayed dashes was not present at startup but within approximately five minutes into operation the reported issue was observed.A lab use only (luo) flow module was substituted and the displayed information was correct as expected.When the dut was reconnected, the abnormal display was immediate this time.The suspect flow module had a lab use only (luo) application board installed with the original generic board and the issue was not observed and the flow was being displayed as intended.It was determined that the application board was defective.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: 10908769
• MDR Text Key: 218675510
• Report Number: 1828100-2020-00462
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 00886799000687
• UDI-Public: (01)00886799000687(11)200312
• 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
• Report Date: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 11/18/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/03/2020
• Initial Date FDA Received: 11/26/2020
• Supplement Dates Manufacturer Received: 05/03/2021
• Supplement Dates FDA Received: 05/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1