The patient was being supported by the centrimag console which was running a centrimag pump.It was reported that the ecmo machine started alarming indicating m3 alarm and the pump still appeared to be running although now making a humming noise, patient stable, visualized blood flowing through the circuit, backup console turned on and flow probe placed confirm flow, albeit 1-1.5 liter lower than the desired 5 liters it had been flowing.A perfusionist was called in and was unable to achieve the rpm's it was set at and flow was dropping.The patient was successfully switch to the backup pump and flows of 5 liters were achieved however the humming continued.No additional information provided.
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Device manufacture date: additional information.Manufactures investigation conclusion: a centrimag primary console was returned and evaluated by a manufacturer¿s technical services representative.During the investigations, the reported faults were seen in the console¿s log-files, and the faulty behavior was also reproduced during intensive tests that were performed using engineering test equipment.The complaint was therefore confirmed.The tests revealed that a temporary cable defect had caused the multiple events at ¿(b)(6)¿ hospital.An intermittent short circuit - which had most probably appeared as electrical sparks - had repeatedly occurred between a motor or bearing phase and broken copper wires of the motor cable¿s outer cable shield (which is connected to earth potential).The fault was/is intermittent.The motor may operate a certain time as intended.However, the fault will re-occur.Therefore, the defective motor was clearly marked with red stickers and stored in the quarantine area for 12 months; it will afterwards be scrapped.The returned console with flow probe operated as intended throughout the tests.Nevertheless, a preventive action was performed on the console: a new motor controller pcb with associated cable was assembled.This preventive replacement action has already been performed before the complaint motor was received at tsg.Additionally, the console¿s damaged front overlay was replaced with a new one.The repaired console sn (b)(4) was finally subjected to the repair and maintenance procedure mp-0138-10, rev.04, together with the returned flow probe sn (b)(4).Both devices passed all tests and were sent back to the distribution center, from where they will be forwarded to the customer.The returned, most probably defective motor sn (b)(4) was scrapped respective clearly marked with red stickers and stored in the quarantine area for 12 months.A new motor was sent as replacement free of charge for the customer.A review of the device history records revealed the device met applicable specifications.No further information was provided.The manufacturer is closing the file on this event.
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