It was reported that the patient was being transported when the ecmo cart rolled over threshold.Centrimag alarmed with two alarms, flow below minimum and set speed not reached, and rpms went to 0 with -1.12lpm flow.After the motor was assessed no movement was felt coming from pump.Before the team was able to clamp the ecmo circuit tubing, rpms returned to 4600 with no intervention on centrimag console.The team waited with the patient and the event happened a second time.The team made the decision to return to the icu to further assess.Upon arrival to the icu the console and motor repeated the above events 4 more times.An emergency change out to the backup console and motor was performed.Patient remained stable.No additional information was reported.
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Manufacturer's investigation conclusion: the reported event of flow below minimum and set speed not reached alarms, as well as a drop in speed, negative flow, and the pump not moving was not confirmed.The centrimag motor was returned for analysis.The motor underwent resistance and insulation testing and functioned as intended.The motor was forwarded to the service depot for analysis.The returned motor was evaluated and tested.The reported event was unable to be duplicated or verified.The motor was run for an extended period of time, including overnight, with the returned and associated console and flow probe.No alarms activated at any point and the flow remained at set levels.The pump speed and flow were checked at every specified speed and the motor remained at normal temperatures at all times.The motor functioned as intended.A full functional checkout was performed, and the unit passed all tests.The motor cable was inspected, and no issues were found.The motor was returned to the customer.The root cause for the reported event was not conclusively determined through this analysis.The 2nd generation centrimag system operating manual 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 also 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 recommended practice whenever there is a 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 back-up motor and console.Switch all components (console, motor, flow probe and cables) simultaneously to continue patient support, and then perform troubleshooting on the non-functioning system when it is no longer being used for patient support.The 2nd generation centrimag system operating manual 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.
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