MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 201-30300

Device Problems No Display/Image (1183); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/08/2019

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not yet been received.The centrimag motor associated with this event is being reported under mfr # 2916596-2020-00551.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported that there was rapid motor deterioration, and a whirring sound was emitted from the device.The console screen then went black and the motor failed.After a few seconds the console rebooted but the decision was made to exchange the entire unit.When the pump head was removed it was noted that the motor was extremely hot.The pump was inserted into a new motor and console.During this exchange the patient experienced mild desaturation but there was no haemodynamic compromise due to the quick exchange of the pump.There were no alarms reported for the event.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the console going blank was confirmed via the log file.The centrimag 2nd generation primary console (serial #: (b)(6)) was returned for analysis to the edc.A log file was downloaded from the returned centrimag 2nd generation primary console (serial #: (b)(6)) showed events spanning approximately 76 days ((b)(6) 2019 ¿ (b)(6) 2020 per time stamp).On (b)(6) 2019 at 14:14, the speed was increased to 5500 rpm and the flow dropped to ~1.6 lpm.A ¿flow below minimum: f3¿ alarm activated.The sub faults ¿sf_ifd_shutdown_detected¿ and ¿sf_ifd_flow_below_min¿ activated.The speed dropped to ~3300 rpm and flow dropped to 0 lpm.The alarms ¿system alert: s3¿, ¿set pump speed not reached: m5¿, and ¿motor alarm: m4¿ activated.The console was evaluated and tested.The system powered on as intended and passed the self-test.The console was tested for an extended operation at a speed of 5000 rpm with a flow of 9 lpm with a test motor.The console functioned as intended and no anomalies were found.The console was returned to the customer.The root cause for the reported event was not conclusively determined through this analysis.The 2nd generation centrimag system operating manual 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." it also 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.It contains a list of console alarms and alerts, as well as appropriate operator response to these events.No further information was reported.The manufacturer is closing file on this event.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 9673915
• MDR Text Key: 179790317
• Report Number: 2916596-2020-00550
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• PMA/PMN Number: K131179
• 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: 04/23/2020

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: No Information
• Device Model Number: 201-30300
• Device Catalogue Number: 201-30300
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/15/2020
• Initial Date FDA Received: 02/05/2020
• Supplement Dates Manufacturer Received: 04/14/2020
• Supplement Dates FDA Received: 04/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1