MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH ADULT FLOW PROBE, CAN

Model Number 201-90421

Device Problem Overheating of Device (1437)

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

Event Date 07/25/2019

Event Type  Injury  

Manufacturer Narrative

Approximate age of device- the centrimag console is not a single use device.Approximate age of the device calculated while in use on the patient is 9 days.The device is expected to be returned for evaluation.It has not yet been received.No further information was provided.A final report will be submitted when the manufacturer's investigation is completed.

Event Description

The patient was being supported on a centrimag device starting (b)(6) 2019.It was reported that on (b)(6) 2019 the device was alarming an m6 "motor over temp" alarm.Flow and rpms were normal.The motor and console were reportedly free from any blankets covering the device and had good air circulation around it.The motor was exchanged.Subsequently, the motor was able to reach normal rpms but the console would not read the flow.The flow probe was exchanged for troubleshooting purpose but the issue did not resolve.An s3 "system alert" alarm was then reported.The console was subsequently exchanged and the issue resolved.No adverse patient consequences were reported.The patient had maps into the 40s but was otherwise asymptomatic.The console and motor will return for investigation.No additional information was provided.

Manufacturer Narrative

Section d3 and g2: correction section h4: additional information manufacturer's investigation conclusion: the reported event of a m6 and s3 alarm as well as the console not reading flow was not confirmed.The centrimag 2nd generation primary console (serial #: (b)(4) was returned for analysis and was evaluated and tested under work order #53875444.The log file was unable to be reviewed due to being overwritten.A new battery pack was installed in the console.The console was tested with the returned and associated flow probe (serial #: (b)(4) and passed all tests.The console, flow probe, and a test motor ran for serval days and the reported event of m6 and s3 alarms was unable to be confirmed.The console and the flow probe functioned as intended.The root cause for the reported event was not conclusively determined through this analysis.The 2nd generation centrimag system operating manualsection 4 entitled "warnings & precautions" warns "one additional 2nd generation centrimag primary console, motor and flow probe are required as backup system in the immediate vicinity of each patient whenever the centrimag or pedivas blood pump is used.The backup console must be connected to the backup motor and to the backup flow probe, have a battery charge sufficient for at least one hour of operation, be connected to ac power (except during transport) and be immediately available should the main console, motor or flow probe experience a malfunction." the 2nd generation centrimag system operating manual section 10 entitled "emergency and troubleshooting" states that "the recommended practice whenever there is a 2nd generation centrimag primary 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 backup motor and console to continue patient support.Do not exchange individual motors or individual consoles during patient support." the 2nd generation centrimag system operating manual has an emergency/troubleshooting section for the 2nd generation console.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.The 2nd generation centrimag system operating manual section 12.1 entitled "appendix i ¿ primary console alarms and alerts" contains a list of console alarms and alerts, as well as appropriate operator response to these events.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH ADULT FLOW PROBE, CAN
• Type of Device: PRIMARY CONSOLE WITH ADULT FLOW PROBE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CA CH-80 05; SZ CH-8005
• MDR Report Key: 8893299
• MDR Text Key: 154302241
• Report Number: 2916596-2019-03697
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 11/12/2019

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: 201-90421
• Device Catalogue Number: 201-90421
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/25/2019
• Initial Date FDA Received: 08/14/2019
• Supplement Dates Manufacturer Received: 11/06/2019
• Supplement Dates FDA Received: 11/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other