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U.S. Department of Health and Human Services

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

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THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 201-90411
Device Problems Pumping Stopped (1503); Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/30/2022
Event Type  malfunction  
Manufacturer Narrative
Related mfr #'s: 3003306248-2022-12525, 3003306248-2022-12526, 3003306248-2022-12528.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.
 
Event Description
It was reported that the patient was placed on mechanical circulatory support in the procedure room.There were no issues with the self-test or support after initiation.The patient was being moved to the stretcher when the monitor suddenly rebooted with "boot error system stopped" message on the monitor.The rotations per minute (rpm) noted to be at 0 on the console.The perfusionist quickly verified that the centrimag had no flow and was able to increase the rpms using the console button.The monitor was unplugged and plugged back in an attempt to reboot without success.The decision was made to change to the backup system.The monitor was eventually able to be rebooted.The perfusionist was able to access the log files which captured a "stopped by user request" message.The backup system was performing without issues until moving the infant to the stretcher.The motor was held by the perfusionist when the system alarmed m5 and the flow stopped.The rpms quickly increased.It was noted that the monitor was not plugged in at this time and the console was on battery power.The perfusionist did not report any issues with the pump being seated improperly in the motor.The site did not have another backup console so they continued to use the backup console for support.The issue did not reoccur.The patient did not experience any adverse events.
 
Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of the backup centrimag system atypically stopping was confirmed; however, the centrimag console was determined to have been unrelated to the cause of the event.A log file was extracted from the returned centrimag console during testing (serial number: (b)(6).The log file contained data from on (b)(6) 2022 at 13:12 to on (b)(6) 2022 at 13:48 per timestamp.The system was observed to be operating around ~3000 rpm / 1.2 lpm throughout the data until on (b)(6) 2022 at 10:00 when the system was manually shut down.The system was not observed to have been in patient use after this time.Atypical events and alarms, including m5 and s3 alarms, were not observed throughout the data.The returned backup centrimag console was tested alongside the returned backup centrimag motor (serial number: (b)(6), evaluated separately).The reported system stop was reproduced upon manipulating the motor¿s cable.The returned motor was also tested alongside a known working test console, and the reported event was further reproduced, narrowing down the cause of the event to the backup centrimag motor.The returned console was functionally tested alongside known working test equipment and was found to perform as intended.As a result, the motor was scrapped, and the console was returned to the customer site after passing all tests per procedure.Review of the device history record for centrimag 2nd gen.Primary console, serial number: (b)(6), showed the device was manufactured in accordance with manufacturing and qa specifications.The 2nd generation centrimag system operating manual section 4 "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." no further information was provided.The manufacturer is closing the file on this event.
 
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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 Key15617904
MDR Text Key307070763
Report Number3003306248-2022-12527
Device Sequence Number1
Product Code DWA
UDI-Device Identifier07640135140702
UDI-Public07640135140702
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131179
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/07/2022
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 Number201-90411
Device Catalogue Number201-90411
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 09/30/2022
Initial Date FDA Received10/17/2022
Supplement Dates Manufacturer Received11/14/2022
Supplement Dates FDA Received12/07/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/26/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient SexMale
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