DIAPACT

Description of Event or Problem

THE DIAPACT CRRT DID NOT ALARM, BUT WAS PULLING AIR THROUGH THE PA PRESSURE SENSOR AND AIR WAS ENTERING THE BLOOD TUBING. THERE WERE NO OUTSIDE LEAKS OR CRACKS. THEY HAD TO CLAMP THE PRESSURE LINE EVERY MINUTE OR SO TO PREVENT THE AIR ENTERING THE BLOOD STREAM. PRESSURE READINGS WERE NEGATIVE AND BELIEVABLE. MFR RESPONSE FOR CCRT, DIAPACT. IT WAS CAUSED BY A CRACKED PA CONNECTOR THAT COULD NOT BE SEEN BY NURSING. LEFT CONNECTORS AND TRAINED IN-HOUSE STAFF ABOUT CHANGING THEM. DID THIS EVENT INVOLVE AN ELECTROPHYSIOLOGY PROCEDURE OR AN ATTEMPTED ELECTROPHYSIOLOGY PROCEDURE? NO. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? CONTINUAL RENAL REPLACEMENT THERAPY. DEVICE USAGE PROBLEM: DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO. OTHER PT INFO: ETHNIC BACKGROUND: WHITE. OTHER THERAPIES IN USE ON PT: NO OTHER THERAPIES. OTHER DEVICES USED IN THERAPY: NONE.

Additional Manufacturer Narrative

THE CRACKED PA (PRESSURE ARTERIAL), SENSOR CONNECTOR WAS REPLACED BY A B. BRAUN TECH DURING THE SVC CALL AND THE TECH VERIFIED THE MACHINE FUNCTIONED PROPERLY AFTER THE PM WAS PERFORMED. THE CUSTOMER WAS ADVISED THAT THEY SHOULD CORRECT ROOT CAUSE OF AIR IN THE TUBING SYS RATHER THAN OVERCOMING THE PROBLEM BY CLAMPING THE LINE. IF AIR DOES ENTER THE SYS AND IS NOT DISSIPATED BY EXPANSION CHAMBERS, THE MACHINE WILL RESPOND WITH AN SAD ALARM. THE ALARM WILL STOP THE BLOOD PUMP AND CLAMP THE LINE UNTIL THE AIR IS COMPLETELY REMOVED. BASED ON DESCRIPTION OF THE INCIDENT, THE CUSTOMER STOPPED THE AIR FROM ENTERING BY CLAMPING ARTERIAL LINE, SO THERE WAS NOT AIR PRESENT AT THE SAD SENSOR TO TRIGGER AN ALARM.