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

Model Number 201-90411

Device Problems Loss of Power (1475); Decreased Pump Speed (1500)

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

Event Date 05/12/2019

Event Type  Injury  

Manufacturer Narrative

The same report is submitted under mfr #2916596-2019-02333 for a different device.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 (cmag) system for the left heart was alarming "set rpm not reached." upon assessment of the motor, the motor seems to be running properly.However, the control panel was off and was not responding to buttons being pushed.The cmag monitor showed that the rpm of the cmag system cannot reach the set rpm of 3900 and the actual rpm is between 3000 and 3050.The cmag system for the right heart was working as intended and no alarms were observed.The patient mental status was unchanged but was little anxious, and svo2 level dropped to as low as 29 settling around 30s.All wires and cables were checked.The clinical team decided to exchange to the backup motor and the backup console.There was no further issues.The patient denied any sign and symptoms of low cardiac output.The patient's svo2 slowly trended back up to 40s, and continued to be monitored.

Manufacturer Narrative

Manufacturer's investigation conclusion: additional information: the serviced and tested unit was returned to the customer site.Although the root cause of the reported event could not be conclusively determined, reports of similar events have been documented and corrective action (capa) has been initiated to investigate the issue.This investigation determined that the root cause of the events captured in the log file was related to the motor used during the event.Action is being taken to address the issue and reports of similar events will continue to be tracked and monitored.No further information was provided.The manufacturer is closing the file on this event.

Manufacturer Narrative

Additional information.Investigation summary: the report of a "set rpm not reached" alarm and inability to change speed was confirmed through the analysis of a data log file retrieved from the returned centrimag 2nd gen primary console.Per the log file's timestamp, on may 13, 2019 the console was supporting a system at a speed of ~3900rpm and a flow of ~4.5lpm for over 59 hours.At approximately 9:10am of the same day the console alarmed with an active system alert:s3 alarm as a result of an active sf_ifd_shutdown_detected fault.Soon after, pump speed dropped down to ~3000rpm and the flow reading became blank.As a result, the console alarmed with set speed not reached:m5 and flow signal interrupted:f2 alerts.Attempts to adjusted pump speed were unsuccessful.These alerts were captured until the pump was disconnected and the console was powered down at approximately 9:21am.The returned centrimag 2nd gen primary console was evaluated and tested by the service depot under.The reported complaint could not be duplicated during their evaluation.The console was tested along with its associated motor and flow probe returned under this complaint.The system was operated for an extended period of time and no issues were observed.No alarms nor flow probe problems were detected.During testing it was noted that the console's battery had expired on 30-nov-2018.The expired battery was replaced with a new one free of charge and battery maintenance was performed successfully.Full functional checkout was performed per the centrimag 2nd gen primary console service process and the unit passed all tests.The returned console was found to function as intended.As a result, the root cause of the reported event could not be correlated to a console related issue.The serviced and tested unit was returned to the customer site.No further information was provided.The manufacturer is closing the file on the 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: 8665175
• MDR Text Key: 146909465
• Report Number: 2916596-2019-02332
• 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,Followup
• Report Date: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-90411
• Device Catalogue Number: 201-90411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 68