MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO ADVANCED PERFUSION SYSTEM 1; APS 1 (HEART LUNG CONSOLE)

Model Number 195274

Device Problems Device Alarm System (1012); Low Audible Alarm (1016)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2014

Event Type  malfunction  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, there were intermittent level sensor alarms with the red level sensor on the perfusion system.The issue occurred during the case repeatedly and the alarm message was not appearing on top of the screen.The device was not changed out, as they continued the case with the nuisance alarm and surgery was successful.The surgical procedure was completed successfully.There wa no delay, no blood loss, nor adverse consequences to the patient.Per the clinical review on (b)(6) 2014: the system-1 (with level sensor) was used with the sorin synthesis oxygenator and venous reservoir.The reservoir is round and they have had coupling issues in the past.During cpb, they had a couple incidents of "level not attached" messages where the sensor lost adequate coupling to the reservoir.There was an audible tone, but no message was posted on the main screen of the central control monitor (ccm).Since the issue cleared so quickly, the ccp could not determine if the coupling issues was with the alert (yellow) or alarm sensor (red).The message tab of the aux screen did post a message related to level.After the second alert, the ccp turned the level sensor off and she added more gel to the sensor(s) face and re-attached to the sensor pad.The fsr also found (days later) the alarm sensor (red) contact surface was slightly concave and this could also have an effect on adequate coupling.The case was completed successfully, without delay and without associated blood loss.There was no harm observed.

Manufacturer Narrative

This complaint is related to mdr #: 1828100-2014-01133.Per field service rep (fsr), the issue occurred so fast that they could not determine if it was the yellow or the red sensor.The fsr could not duplicate the reported complaint but he found the contact surface of red sensor part number 5878, was slightly concave and may not have been making good contact with the reservoir.The fsr replaced the red level sensor.The fsr downloaded the data logs and will submit to the manufacturer for further evaluation.

• Brand Name: TERUMO ADVANCED PERFUSION SYSTEM 1
• Type of Device: APS 1 (HEART LUNG CONSOLE)
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson rd.; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 4366137
• MDR Text Key: 5265838
• Report Number: 1828100-2014-01139
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/09/2014

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: 195274
• Device Catalogue Number: 195274
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2014
• Initial Date FDA Received: 12/22/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: SORIN SYNTHESIS OXYGENATOR; VENOUS RESERVOIR