MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE

Model Number 201-90411

Device Problems Pumping Stopped (1503); Vibration (1674); Noise, Audible (3273)

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

Event Date 05/09/2019

Event Type  Injury  

Event Description

It was reported that patient was on centrimag (cmag) support during a surgical procedure that was unrelated to the patient being placed on cmag.Towards the end of the procedure, a humming and clicking noise was heard coming from the cmag motor.The clinical team observed the rpms drop from 4300 to 3250 and the flow waveform on the cmag monitor dropped to 0 sounding an alarm.The system was stopped.The cmag system was replaced with a backup and the system was initiated again.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of a speed and flow drop and a flow below minimum alarm was confirmed via the log file; however, the motor making a clicking noise was not confirmed.The centrimag 2nd generation primary console was returned for analysis.A log file was downloaded from the console for review.A review of the downloaded log file showed event spanning approximately 20 days (b)(6) 2019 ¿ (b)(6) 2019 per time stamp).On (b)(6) 2019, the sub fault ¿sf_ifd_shutdown_detected¿ and triggered the alarms ¿system alert: s3¿ and ¿set pump speed not reached: m5¿.The alarms were able to be muted and cleared.The sub fault ¿sf_sps_fan_speed¿ activated at this time stamp as well.The speed dropped to ~3200 rpm and the flow dropped to 0 lpm.At 14:40, the alarm ¿motor disconnected: m2¿.At 14:41, the alarm ¿flow below minimum: f3¿ activated.The returned console was forwarded to the service depot.The console was evaluated and tested under work order # (b)(4).The service depot was unable to verify or duplicate the reported event of a clicking noise from the motor, a speed and flow drop, and a flow below minimum alarm.The console was tested for an extended period of time with a test motor and the returned and associated motor, flow probe, and monitor.No alarms or issues occurred with the flow.No faults were found, and the console performed as intended.Reports of similar events will continue to be tracked and monitored.The root cause for the reported event of a clicking noise from the motor, a speed and flow drop, and a flow below minimum alarm was not conclusively determined through this analysis.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE
• Type of Device: PRIMARY CONSOLE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 8647214
• MDR Text Key: 146274584
• Report Number: 2916596-2019-02312
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: 07640135140702
• 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: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: 201-90411
• Device Catalogue Number: 201-90411
• Device Lot Number: 6722544
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 150