Evaluation of the returned device found the proportional valve and the balance regulator, on the gas blender, were out of calibration.The fio2 knob was loose and a set screw was missing.This did not allow the balance regulator to adjust the fio2 properly.Additional information received by the customer indicate that this device is only checked for functionality and has not been overhauled or preventative maintenance performed on it.A dhr review of this device found no indication that there were any relevant discrepancies during manufacture of the device, and no non-conformance that could have caused or contributed to the reported issue.Based on the age of the device, it is likely that normal wear and tear contributed to the malfunction.At this time there is no evidence that a manufacturing non-conformity contributed to the reported complaint, and the instructions for use were reviewed and determined to provide adequate instructions and warnings for the safe and effective use of the device.Therefore, no corrective or preventative actions are necessary.All complaints are trended and reviewed by management on a monthly basis.As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted.Manufacturer reference file #: (b)(4).
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Customer reported patient was on ecmo machine and o2 was set to 100%, but found that blood was wrong color, so they switched blenders.No injury to the patient as they noticed immediately, and took immediate action.
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