Related manufacturer's report #s: 3003306248-2021-04031, 3003306248-2021-04032.It was reported that the patient was on centrimag support, when an s3 alarm displayed.The patient's physicians proceeded to change the flow probe.After the flow probe was exchanged, the flow value was no longer visible and the alarm persisted.The patient's spo2 levels dropped.The console and the motor were exchanged, and the system then continued working without any further alarms.
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Manufacturer's investigation conclusion: 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, including s3, m3, m2, f1, and f2 alarms.The reported event of a s3 alert and no flow displayed was confirmed via the log file.The centrimag motor (serial #: (b)(6) ) was returned for analysis and a log file was downloaded from the returned and associated centrimag 2nd generation primary console (serial #: (b)(6) ) for review.A review of the downloaded log file showed events spanning approximately 4 days ((b)(6) 2021 per time stamp).Events occurring on (b)(6) 2021 took place during lab testing at abbott.On (b)(6) 2021 at 02:45:59 the console was powered on.The console alarmed for ¿pump not inserted: m3¿ and ¿flow sensor disconnected: f1¿ at 02:46:20 before the date and time of the system was synced.At 03:02:14, the support type was selected.A ¿motor disconnected: m2¿ alarm activated at 03:03:40 and was followed by a ¿system alert: s3¿ at 03:03:42.The f1, m2 and m3 alarms were able to be cleared; however, continued to intermittently activate.At 03:11:41 the motor speed was increased to 1500 rpm before being decreased to 0 rpm.The speed was changed several times, and always increased as intended; however, the flow remained at 0 lpm.¿flow signal interrupted: f2¿ alarms intermittently activated and cleared during this event.The console was powered down at 04:30:30.There were no other notable alarms active in the log file.The centrimag motor was returned for analysis and was evaluated and tested.The reported event was unable to be reproduced.The motor was tested with the returned and associated centrimag flow probe, centrimag 2nd generation primary console, monitor to console cable, and a mock loop for several days and there were no alarms observed.The motor was tested independently as well as operated as intended.The motor cable was inspected, and no anomalies were observed.The motor was returned to the customer.The root cause for the reported event was unable to be conclusively determined through this analysis.No further information was provided.The manufacturer is closing the file on this event.
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