On (b)(6) 2019 haemonetics received a reported incident of a cell saver which was observed to have a damaged centrifuge with a burning smell noted upon further inspection.On may 6 2019 a haemonetics field service engineer evaluated the device and confirmed that the centrifuge motor had failed.The fse replaced the centrifuge assembly and recalibrated the device to ensure it meets manufacturer specifications.There was no patient involved in a procedure at the time the failure was discovered.A failed centrifuge motor will prevent the device from completing the power on self test (post) protocol prior to being able to initiate any procedures.The device will detect any hardware failures and will not pass the post until the device has been repaired, preventing risk of injury to the patient as a result of hardware failure.There were no injuries reported as a result of this incident, however haemonetics has previously submitted reports of thermal decomposition observed within a device, as a result this incident is deemed reportable.
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