Description of Event or Problem · 1
THE AIR ALARM ON THE DIALYSIS MACHINE WENT OFF AND THE PATIENT WAS FOUND UNRESPONSIVE AND IN CARDIAC ARREST. THE ARTERIAL DIALYSIS LINE WAS FOUND DISCONNECTED WITH BLOOD NOTED. AIR WAS PRESENT IN THE DIALYSIS SYSTEM UP TO THE SUBCLAVIAN CATHETER. DESPITE AGGRESSIVE RESUSCITATION, THE PATIENT EXPIRED. THE ARTERIAL-VENUOUS BLOOD TUBING (ONE TIME USE) WAS ALSO IN USE.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE NOT SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-JAN-94. SERVICE PROVIDED BY: USER FACILITY BIOMEDICAL/BIOENGINEERING DEPARTMENT. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.