MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EM-TEC ADULT FLOW PROBE (VAS/ECMO); CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 201-90401

Device Problem Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/23/2022

Event Type  malfunction  

Event Description

It was reported that while running the unit for a few days, the centrimag had m3 and f2 alarms.The alarms went off once a head was attached to the motor and the flow probe was connected to the tubing and the system was run.On (b)(6) 2022,after taking the head out of the motor and the flow probe off and starting the system, the m3 and f2 alarms came on.The unit was left on for 5 minutes and when turning it off an s3 alarm popped off.The alarm stayed after the console was rebooted.The products were removed from use.Related mfr #s: 3003306248-2022-11273 and 3003306248-2022-11274.

Manufacturer Narrative

Incidental findings: it was noted during investigation that there were loose wires on speaker 2 of the console, and the console battery was expired.The reported event of m3, s3, and f2 alarms were confirmed.The centrimag 2nd generation primary console (serial #: (b)(4) was returned for analysis and a log file was downloaded for review with events spanning approximately 5 days (b)(6) 2022 ¿ (b)(6) 2022, (b)(6) 2022, (b)(6) 2022, (b)(6) 2022 per time stamp).The console was powered on at 17:28 on (b)(6) 2022.¿pump not inserted: m3¿ and ¿flow signal interrupted: f2¿ alarms were active following start up.At 17:30, a ¿system alert: s3¿ alarm activated and was triggered by the sub-fault ¿sf_sps_power_button_inconsistent¿.The console was powered off.There were no other notable alarms active in the log file.The centrimag 2nd generation primary console was returned for analysis to the european distribution center (edc) and was evaluated and tested.The console was run for a few days before a s3 alarm appeared.The reported event of m3 and f2 alarms were unable to be reproduced.The sps printed circuit board (pcb) and power button assembly were replaced and forwarded to product performance engineering (ppe) for further analysis.Upon further analysis with ppe, the sps pcb was in unremarkable condition.The sps pcb was connected to a test console and the console was powered on and a ¿system alert: s3¿ alarm was active.The motor speed was able to be set; however, the speed was not able to pass 5150 rpm despite being set at a higher value of 5500 rpm.The flow was blank and not able to be displayed and ¿flow signal interrupted: f2¿ alarms were intermittently active.Changing the flow probe did not resolve this issue.The console was power cycled, and the alarm resolved.The returned power button was connected and there were no issues noted.During troubleshooting, the console was power cycled several times, and the reported and observed issues were unable to be reproduced again.The root cause for the reported event was conclusively determined to be due to an issue with the sps pcb; however, a further root cause was unable to be determined.The device history records were reviewed for the centrimag 2nd generation primary console (serial #: (b)(4) and the console was found to pass all manufacturing and qa specifications.The console battery (serial #: (b)(4) was not shipped with this console.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 ¿console alarms and alerts¿ addresses how to interpret and troubleshoot all system alarms including s3, m3, and f2 alarms.The 2nd generation centrimag system operating manual table 15 entitled ¿console maintenance schedule¿ states that the battery needs to be replaced every 2 years.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EM-TEC ADULT FLOW PROBE (VAS/ECMO)
• 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: 15691867
• MDR Text Key: 306828983
• Report Number: 3003306248-2022-14504
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-90401
• Device Lot Number: 6636564
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2018
• 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