DIAPACT

Additional Manufacturer Narrative

SINCE A SPECIFIC ALARM CODE COULD NOT BE IDENTIFIED, AND THE CLINICIAN ENGINEER CONFIRMED THE MACHINE WAS WITHIN CALIBRATION AT THE TIME OF THE INCIDENT, THE EXACT NATURE OF THIS INCIDENT COULD NOT BE DETERMINED. NO SPECIFIC CONCLUSIONS CAN BE DRAWN. THE CLINICAL ENGINEER RELEASED THE MACHINE BACK INTO USE BASED ON THE ASSESSMENT. THERE WERE NO ADDITIONAL ALARMS. B. BRAUN ADVISED CUSTOMER ABOUT USING HAND CRANK IN CASE OF MACHINE OR POWER FAILURE, TO PROPERLY RETURN BLOOD TO THE PT AND TO PROPERLY CONFIRM CALIBRATION OF ALL PARAMETERS.

Description of Event or Problem

AS REPORTED BY THE USER FACILITY: MACHINE EXPERIENCED A FATAL ERROR DURING THERAPY, RESULTING IN PUMPS STOPPING. USER DID NOT UTILIZE HAND CRANK TO RETURN PT'S BLOOD. BLOOD LOSS ESTIMATE WAS 200CC. ADDITIONAL INFO PROVIDED BY THE FACILITY INDICATED THE CLINICIAN DID NOT REPORT THE ACTUAL SPECIFIC ALARM CODE TO THE CLINICAL ENGINEER. THE CLINICAL ENGINEER CONDUCTED A THOROUGH INSPECTION OF THE MACHINE AND RAN SIMULATED THERAPY FOR SEVERAL HOURS TO TEST MACHINE. THE MACHINE FUNCTIONED PROPERLY. THE MACHINE WAS DETERMINED TO BE WITHIN CALIBRATION AT THE TIME OF THE INCIDENT.