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

Model Number 201-90411

Device Problem No Display/Image (1183)

Patient Problem No Patient Involvement (2645)

Event Date 06/26/2019

Event Type  Injury  

Manufacturer Narrative

No patient was involved.The age of device cannot be calculated with the current information.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 cmag screen went blank and also gave a b4 error code.These both appear to have self corrected.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of a blank console and a b4 alarm was confirmed via the log file.The centrimag 2nd generation primary console was returned for analysis.A log file was downloaded from the returned console.A review of the downloaded log file showed events spanning approximately 16 days ((b)(6) 2019 per time stamp).The console was operating the motor at a speed of ~4800 rpm with a flow of 1.93 lpm.On (b)(6) 2019 at 15:11, the sub fault sf_ifd_shutdown_detected activated and triggered the alarms ¿system alert: s3¿ and ¿set pump speed not reached: m5¿.The speed dropped to ~3500 rpm and the flow dropped to 0 lpm.The s3 and m5 alarms were able to be muted at 15:12.The system was powered off at 15:23 before being powered on again at 19:44.A ¿battery maintenance required: b4¿ alarm was active at 19:45.The system was powered off again at 19:46.The console was forwarded to the service depot for analysis and was evaluated and tested.The reported event was unable to be verified or duplicated.The console was tested for an extended period of time with a test motor and the returned and associated flow probe.The console¿s screen did not go blank and no alarms activated.The console functioned as intended.The console¿s battery underwent a successful battery maintenance.A full functional checkout was performed, and the unit passed all tests.The console was returned to the customer.Reports of similar events have been documented and corrective action had been initiated to investigate the issue further.The investigation has determined that the issue is not related to a 2nd generation primary console related issue.Reports of similar events will continue to be tracked and monitored.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".The 2nd generation centrimag system operating manual 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.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: 8797633
• MDR Text Key: 151270994
• Report Number: 2916596-2019-03237
• 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: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: 201-90411
• Device Catalogue Number: 201-90411
• Device Lot Number: 6440071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1