MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR, US

Model Number 102956

Device Problem Decreased Pump Speed (1500)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/03/2019

Event Type  Injury  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported that the centrimag system was running at 3600 revolutions per minute.The system alarmed set pump speed not reached (system alert s3).The screen displayed "- - -".The centrimag was being used on a patient at the time of the alarm.It is unknown whether pressing the alarm acknowledge button resolved the alarm as the nurse in the intensive care unit changed the patient over to a different motor and console.The patient did experience interruption in support, however, no adverse effects took place.The nurse used backup equipment right away.No further information was provided.

Manufacturer Narrative

Manufacturer's investigation conclusion: the report of a system alert:s3 and set pump speed not reached:m5 alarms was confirmed through the analysis of a submitted picture.The picture showed a mag monitor event history displaying system alert:s3, set pump speed not reached:m5, and motor alarm:m4 alarms which activated at ~18:44 on (b)(6) 2019, per the timestamp.These alarms were preceded by a system shutdown initiated event.The alarms were muted by the user at ~18:45.System uptime was noted to be over 51 hours at the time of the event.No further relevant information could be obtained from the submitted picture.As a result, the report of the screen displaying "---" could not be confirmed.The centrimag motor (sn (b)(6) was not returned for analysis.As a result, the root cause of the reported event could not be conclusively determined.Reports of similar events will continue to be tracked and monitored.The 2nd generation centrimag system operating manual section 10 provides information regarding emergencies/troubleshooting.The recommended practice whenever there is a console or motor malfunction is to replace the console and motor as a set.Remove the blood pump from the malfunctioning motor and console, and place the blood pump in the back-up motor and console.Switch all components (console, motor, flow probe and cables) simultaneously to continue patient support, and then perform troubleshooting on the non-functioning system, when it is no longer being used for patient support.No further information was provided.The manufacturer is closing the file on this event.The console in use during this event is reported under mfr # 2916596-2019-03588.

• Brand Name: CENTRIMAG MOTOR, US
• Type of Device: CENTRIMAG MOTOR
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CA CH-80 05; SZ CH-8005
• MDR Report Key: 8855960
• MDR Text Key: 153119480
• Report Number: 2916596-2019-03587
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140078
• UDI-Public: 07640135140078
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 102956
• Device Catalogue Number: 102956
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 88