THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR, US; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
|
Back to Search Results |
|
Model Number 102956 |
Device Problems
Mechanical Problem (1384); Infusion or Flow Problem (2964)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 07/23/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
No further information was provided.The manufacturer is closing the file on this event.
|
|
Event Description
|
Related manufacturer¿s report 2916596-2020-03881.It was reported that the patient experienced m2, f2 and b6 alarms during startup, with the motor plugged in.The site communicated that the console was plugged into the wall and powered on when the alarms visualized m2 motor disconnected, f2 flow signal interrupted.The motor was unplugged from the console, the prongs and cable inspected but no visual imperfections were noted.The site plugged the motor back in, and the m2 alarm was still present.The site inserted the training loop into the motor head, attached flow probe which resolved the f2 alarm.The site then removed motor from console, plugged in demo motor (not for patient use) visualized resolution of m2 alarm, increased rpms and confirmed properly functioning.
|
|
Manufacturer Narrative
|
Section b5: correction: patient involvement was incorrectly reported in previous report.There was no patient involvement.Manufacturer's investigation conclusion: the reported event of m2 alarms was confirmed.The centrimag motor (serial #: (b)(6) was returned for analysis and was evaluated at the product performance engineering (ppe) lab.The motor cable was inspected, and an open connection as found.The motor was connected to a mock loop and a m4 alarm was noted.The motor was making grinding noises.The motor was forwarded to the service depot.The motor was then evaluated and tested at the service depot and the reported event was able to be duplicated and confirmed.The motor was connected to a test console and flow probe and a motor disconnected:m2 alarm activated and could not proceed further.The motor cable was inspected, and the motor was scrapped due to a damaged motor cable.The root cause for the reported event was conclusively determined to be due to a damaged motor cable.The device history records were reviewed for the centrimag motor (serial #: (b)(6), and the motor was found to pass all manufacturing and qa 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 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.No further information was provided.The manufacturer is closing the file on this event.
|
|
Event Description
|
It was reported that the console was a back up console and was powered on as a daily check by the ecmo specialist when the malfunction was identified.There was no patient involvement.
|
|
Search Alerts/Recalls
|
|
|