The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.The complaint cannot be confirmed since the device was not available for evaluation.The exact root cause cannot be determined.The device history record (dhr) review determined that the device was in a conforming state when released from terumo control.There is no indication that any manufacturing issues may have led to this event.Currently no action is recommended since this risk evaluation is within the predetermined limits in the failure mode and effects analysis (fmea).Sample was not available.
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