Manufacturer¿s investigation conclusion: the reported event of the centrimag system emitting an atypical smell was not confirmed.The centrimag motor (serial number (b)(4) was not returned for analysis.The equipment was not in use with a patient at the time of the reported event, and per additional information, the issue was stated to have resolved.The root cause of the reported event was unable to be conclusively determined through this analysis.Review of the device history record for the centrimag motor, serial number (b)(4), showed the device was manufactured in accordance with manufacturing and qa specifications.The 2nd generation centrimag system operating manual section 4 ¿warnings and 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." no further information was provided.The manufacturer is closing the file on this event.
|