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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 Insufficient Information (3190); Unexpected Shutdown (4019)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/08/2021
Event Type  malfunction  
Event Description
Related manufacturer¿s report #3003306248-2021-01083.It was reported that the site had a centrimag motor and console fail while attached to the patient.The console had message motor disconnected after the motor had stopped running.
 
Manufacturer Narrative
Section d4: expiration date was inadvertently reported in initial report and is not applicable for this device.Manufacturer's investigation conclusion: the reported event of a motor disconnected alarm and the motor stopping was not confirmed.The centrimag 2nd generation primary console (serial #: (b)(6) was returned for analysis and a log file was downloaded for review.A review of the downloaded log file showed events spanning approximately 3 days ((b)(6) 2021 per time stamp).Events occurring on (b)(6) 2021 took place during lab testing at abbott.There were no events related to the reported event active in the log file.The motor was at a speed of 0 rpm and a flow of 0 lpm throughout the entire log file.The centrimag 2nd generation primary console was returned for analysis and was tested with the returned and associated centrimag motor as well as a test motor and flow probe for an extended period of time, including overnight.The console was able to keep the motor at the set speed and flow.No issues or alarms were observed, and pump operation was not affected.A full functional checkout was performed, and the console operated as intended.The root cause for the reported event was unable to be conclusively determined through this analysis.The 2nd generation centrimag system operating manual (rev.11) 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 (rev.11) 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 (rev.11) section 12.1 entitled "appendix i ¿ primary console alarms and alerts" contains a list of console alarms and alerts, as well as appropriate operator response to these events, including m2 alarms.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 qa specifications.No further information was provided.The manufacturer i s 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
MDR Report Key11576470
MDR Text Key245988642
Report Number3003306248-2021-01084
Device Sequence Number1
Product Code DWA
UDI-Device Identifier07640135140702
UDI-Public07640135140702
Combination Product (y/n)N
PMA/PMN Number
K131179
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 05/17/2021
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 Expiration Date09/30/2019
Device Model Number201-90411
Device Catalogue Number201-90411
Device Lot Number6141145
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/23/2021
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/08/2021
Initial Date FDA Received03/26/2021
Supplement Dates Manufacturer Received05/14/2021
Supplement Dates FDA Received05/17/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age43 YR
Patient Weight167
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