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 Problem Device Alarm System (1012)

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

Event Date 09/16/2020

Event Type  malfunction  

Manufacturer Narrative

The field service representative (fsr) had the manufacturer's technical support specialist review the data log which found the alarms were coming from the alert level sensor.The fsr replaced alert level sensor and also the alarm level sensor as a precaution.The unit operated to the manufacturer's specifications.The alarm level sensor is pn 195274 sn (b)(4).The suspect devices were returned to the manufacturer for further evaluation.

Event Description

It was reported that the heart lung machine (hlm) was giving an alarm, believed to be due to the level sensor.No other details regarding the nature of this event were provided.

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.

Manufacturer Narrative

Per the data log analysis, the complaint indicated that the issue occurred on (b)(6) 2020, but the log review shows the issue likely occurred on (b)(6) 2020.On (b)(6) 2020 the level module was reporting that the alert probe status was changing from coupled to disconnected back to coupled.This occurred 22 times while the level detection was enabled.This will cause an alert tone to occur as reported.All but one of the 22 alerts cleared so fast that the ccm was not notified of what caused the alert.The log review confirms the complaint.During laboratory analysis, the product surveillance technician (pst) verified the reported issue.The level sensor had a short where the cable connects to the sensor.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 received that the issue happened during a cardiopulmonary bypass (cpb) procedure.The team did not see a message displayed on the central control monitor (ccm) and could not identify the alarm.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review: during a cpb procedure on (b)(6) 2020 the team had a low level alert audibly alarm (decouple and recouple) without a message in the auxiliary tab or a visual indication on the ccm.The team had enough volume in their reservoir and had no issues prior with the level sensing pads, gel or system.They continued the procedure without issue.There was no delay in the continuation of the surgical procedure.There was no harm or blood loss associated 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: 10652538
• MDR Text Key: 224410867
• Report Number: 1828100-2020-00384
• 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,Followup
• Report Date: 12/03/2020

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: 195215
• Device Catalogue Number: 195215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/16/2020
• Initial Date FDA Received: 10/08/2020
• Supplement Dates Manufacturer Received: 10/19/2020; 11/12/2020
• Supplement Dates FDA Received: 11/09/2020; 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1