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U.S. Department of Health and Human Services

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

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THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EM-TEC ADULT FLOW PROBE (VAS/ECMO); CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS Back to Search Results
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.
 
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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 Key15691867
MDR Text Key306828983
Report Number3003306248-2022-14504
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
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
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number201-90401
Device Lot Number6636564
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/25/2022
Initial Date FDA Received10/28/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/06/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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