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); Output Problem (3005)

Patient Problem Death (1802)

Event Date 12/16/2019

Event Type  Death  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the flow sensor failed and showed dashes.As a result, an alternate device was employed.The surgical procedure was not completed successfully.There was no delay, however there was a 28 liters (l) of blood loss and the patient had died.The end-user claims that the alleged failure of the flow sensor did not contribute to the patient's blood loss, nor the patient's death.

Manufacturer Narrative

Updated blocks: d10, h3, and h6.During laboratory analysis, the product surveillance technician (pst) observed the customer flow pod assembly using a laboratory use only (luo) small roller pump along with luo flow sensor and a luo water loop connected in ambient temperature to perform as normal.The flow module performed as expected for 18 hours 40 minutes without errors logged.Per data log analysis, it was determined that the log only covers 25-feb-2020 (when the log was exported) and 05-dec-2019.There was a little over 10 minutes of log entries on 05-dec-2019, most occurred in about one minute.It looks like the flow sensor was detecting intermittent air or not fully coupled to the tubing.This caused many events which quickly flushed the log.The date does not match the reported incident date of 16-dec-2019.The log indicates the system was not used on the 16-dec-2019 date.

Manufacturer Narrative

Updated block: h6.The reported complaint could not be 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

Per clinical review: on (b)(6) 2019, the team set up the case without issue and commenced cardiopulmonary bypass (cpb).During the procedure the local display and the display on the central control monitor (ccm) for the flow from the arterial centrifugal pump began reading dashes.The perfusionist confirmed that the display was still showing the revolutions per minute (rpms).The perfusionist tried another flow probe and the system was still reading dashes.To mitigate the issue she was able to have another perfusionist retrieve a flow module from a heart lung machine (hlm) that was not in use and replace the module, plug in the original flow probe, and the actual flow in liters per minute (l/min) was able to be displayed on both the local display and ccm.The event did not delay the continuation of the surgical procedure.There was no harm or blood loss associated with the temporary loss of measured flow in l/min, but the patient did expire due to other complications.The perfusionist stated that the patient's blood loss was 28 liters due to other complications, not affiliated with the event.

• 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: 9555305
• MDR Text Key: 173842089
• Report Number: 1828100-2020-00003
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 00886799000687
• UDI-Public: (01)00886799000687(11)171227
• Combination Product (y/n): N
• PMA/PMN Number: K022947
• 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,Followup
• Report Date: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/16/2019
• Initial Date FDA Received: 01/06/2020
• Supplement Dates Manufacturer Received: 01/22/2020; 02/13/2020; 03/19/2020
• Supplement Dates FDA Received: 02/12/2020; 03/09/2020; 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death