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

Model Number 195240

Device Problems Failure To Adhere Or Bond (1031); Out-Of-Box Failure (2311)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/13/2018

Event Type  malfunction  

Event Description

It was reported that during the use of the device for a cardiopulmonary bypass (cpb) procedure, the level alarm was intermittently disconnecting and reconnecting so quick that the message was not being displayed.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review: during set up for a cpb procedure on (b)(6) 2018, the perfusionist (ccp) heard an audible level alert but did not get the message on the system.He proceeded to troubleshoot the system by initially completely taking the level sensor off of the reservoir, and was expecting a response to go to coast, but he had forgotten that the response was only a message and does not induce a response to the centrifugal pump.The manufacturer's technical support and clinical services spoke with him reminding of that response and what he should expect.He proceeded to change out the level sensor cable, and still had the audible alert message with no message in the message area regarding level alarms.He confirmed that the module was green, but also decided to exchange that out to see if the module was the source of his audible alarm.Still a concern, but he felt the system was safe and proceeded to go on bypass.He continued the procedure, but would randomly receive the same audible noise attached of an indication of a level alarm, but no messages appeared in either the messaging area or the auxiliary message tab.The manufacturer's field service representative visited the user facility to investigate the concern, and found no functional issue with either the heart lug machine (hlm), the level module or the level sensor cables.What was occurring was the level alarm sensor pad was intermittently getting disconnected, and was so quick to resolve and reengage with the reservoir that the audible noise would occur, but the message was not being displayed.The team at user facility uses fx reservoirs, they per the manufacturer's instructions for use (ifu) for the hlm, put their pads on and wait the five minutes to load the sensor into the pad.They do use the gel to engage the sensor on the reservoir, and do not put the pads on a labeled area on the reservoir.The incident did not delay the surgical procedure, and there was no harm or blood loss associated with the event.

Manufacturer Narrative

The reported complaint was confirmed.Per data log analysis, on (b)(6) 2018 the level was reporting many status changes of the alarm probe.The probe was mostly toggling from coupled to disconnected and sometimes uncoupled to disconnected.This was happening so fast that a message may not be displayed in the auxiliary messages tab.The field service representative (fsr) was unable to duplicate the reported complaint.He checked the condition of level sensors and performed release testing.The unit operated to the manufacturer's specifications.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: 7657452
• MDR Text Key: 113004094
• Report Number: 1828100-2018-00355
• 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
• Report Date: 09/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 195240
• Device Catalogue Number: 195240
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FX RESERVOIR; FX RESERVOIR