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

Model Number 195215

Device Problems Connection Problem (2900); Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/05/2020

Event Type  malfunction  

Manufacturer Narrative

The field service representative (fsr) could not verify the problem.The yellow alert sensor was slightly worn, but the unit tested normally.The unit operated to the manufacturer's specifications.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, a level sensor 'detached' message displayed on the central control monitor (ccm).No other details regarding the nature of this event were provided.

Manufacturer Narrative

Per the field service representative, the user facility's manufactured trained biomedical technician replaced the worn level sensor.

Manufacturer Narrative

Per the field service representative, the user facility's manufacturer trained biomedical technician ordered a new level sensor and replaced the old level sensor.

Manufacturer Narrative

Updated block: b5 per data log analysis, the level log shows many alert probe status changes from coupled to uncoupled.This will cause a 'level not attached' message and a 'level not attached alert' if the level detection is turned on.This usually indicates a problem with the level pad placement or the probe itself (less likely).The log confirms the complaint.

Event Description

Per clinical review: the manufacturer's clinical specialist spoke with the perfusionist regarding an incident the team had on (b)(4) 2020 with the yellow level sensor during a cardiopulmonary bypass (cpb) procedure.No other information was given at this point.The level sensing system during a procedure gave the team a level not attached message.It is unknown what reservoir they use, if they wait the five minutes prior to attaching the sensors to the level sensor adhesive pads, or if they had a concern about the gel that the sensors need attachment with.It is unknown about a delay or harm.There is routinely no blood loss due to this issue.There is typically no delay or harm due to this issue.

Manufacturer Narrative

The reported complaint was confirmed.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: 10924837
• MDR Text Key: 218946623
• Report Number: 1828100-2020-00464
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 0088799000717
• UDI-Public: (01)0088799000717(11)180202
• 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,Followup,Followup
• Report Date: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 195215
• Device Catalogue Number: 195215
• 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