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 Consequences Or Impact To Patient (2199)

Event Date 09/20/2018

Event Type  malfunction  

Manufacturer Narrative

Per the user facility's perfusionist, after the procedure the whole unit was powered down and restarted and the level sensor was working fine.The field service representative (fsr) was unable to duplicate the reported complaint.He did observe the pad of the level sensor to be slightly concave so he replaced it.The unit operated to the manufacturer's specifications.The suspect part was returned to the manufacturer for further evaluation.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, there were intermittent 'level sensor not attached' alarms.The sensor was cleaned with alcohol and used for the remainder of the procedure.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Event Description

Per clinical review: during a cardiopulmonary bypass (cpb) procedure on (b)(6) 2018, the level alert message alarmed when the level condition was not being met (alarming when volume was above level sensor).The perfusionist proceeded to turn the system off, wipe the sensor with alcohol and reattach it to the pad.This did not stop the alarm system, therefore he opted to turn off the level sensing system and continued the case without the use of the level sensing system.He stated that he does not use the gel to adhere the sensor to the reservoir, nor does he wait the instruction for use (ifu) suggested five minutes curing period on the pad when loading the sensor cables.He stated he did not have problems with using his method of engaging the level sensing system prior to this event.I have instructed him on the ifu on the level sensing system.There was no harm, blood loss or delay in the surgical procedure related to the level alarm system concerns.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) observed an intermittent disconnected alert message due to concaving of the sensor membrane.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: 7953315
• MDR Text Key: 123362172
• Report Number: 1828100-2018-00549
• 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: 11/08/2018

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: 10/03/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/21/2018
• Initial Date FDA Received: 10/10/2018
• Supplement Dates Manufacturer Received: 10/18/2018
• Supplement Dates FDA Received: 11/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1