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

Model Number 201-90411

Device Problems Electrical Power Problem (2925); Unexpected Shutdown (4019)

Patient Problem Cardiac Arrest (1762)

Event Date 06/21/2023

Event Type  Injury  

Manufacturer Narrative

No additional information has been provided.A supplemental report will be submitted once the manufacturer's investigation is complete.

Event Description

Related manufacturer report number: 3003306248-2023-01956.It was reported that the centrimag was supporting the patient and unexpectantly cut out and the patient went into cardiac arrest.The device was turned off and back on and the console returned to normal flow.

Event Description

It was reported that the centrimag was supporting the patient and unexpectantly cut out and alarmed for zero flow, the patient went into cardiac arrest.The device was turned off and was exchanged out for a new one.The motor was also exchanged.Related manufacturer report numbers: 3003306248-2023-01956 and 3003306248-2023-01968.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the console shutting down and a low flow alarm was confirmed via the log file.The centrimag 2nd generation primary console (serial #: (b)(6)) was returned for analysis and a log file was downloaded for review with events spanning approximately 3 days (20jun2023 ¿ 22jun2023 per time stamp).The console was operating a motor at a speed of ~3800 rpm with a flow of ~5.19 lpm.On 21jun2023 at 10:31, a ¿sf_ifd_shutdown_detected¿ sub-fault activated indicating that the console display turned off.Subsequently this triggered ¿flow signal interrupted: f2¿, ¿flow below minimum: f3¿, and ¿motor alarm: m4¿ alarms as well as an atypical ¿motor disconnected: m2¿ alarm.The flow and motor speed dropped to 0 lpm and 0 rpm respectively.The ¿sf_ifd_shutdown_detected¿ sub-fault continued to intermittently activate and a ¿system alert: s3¿ alarm.The log file then indicated that the user pressed the power button to restart the console as indicated in the reported event.The console was powered cycled at 10:46 which appears consistent with the reported console exchange.There were no other notable events active in the log file.The centrimag 2nd generation primary console was returned for analysis to the european distribution center (edc) where it was functionally tested and operated as intended.The reported event was unable to be reproduced during testing and forwarded to product performance engineering (ppe) for further review.Upon further analysis with ppe, the returned console was tested with the returned and associated centrimag motor and flow probe for extended operation.No alarms were active during testing and the system operated as intended.The reported event was unable to be reproduced.The root cause for the reported event was unable to be conclusively determined through this analysis.The device history records were reviewed for the centrimag 2nd generation primary console (serial #: (b)(6)) and the console was found to pass all manufacturing and quality assurance specifications.The 2nd generation centrimag system operating manual section 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 table 16 entitled ¿consoles alarms & alerts¿ states how to interpret and troubleshoot all system alarms including f2, f3, m2, m4, and s3 alarms.The 2nd generation centrimag system operating manual table 15 entitled ¿console maintenance schedule¿ states to replace the internal battery every 2 years and perform battery maintenance every 6 months.No further information was provided.The manufacturer is closing the 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
• Manufacturer (Section G): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 17212715
• MDR Text Key: 317968368
• Report Number: 3003306248-2023-01955
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: 7640135140702
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K131179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 201-90411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/22/2023
• Initial Date FDA Received: 06/27/2023
• Supplement Dates Manufacturer Received: 10/25/2023
• Supplement Dates FDA Received: 11/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other