Description of Event or Problem · 1
EMERGENCY DEPARTMENT TREATMENT OF PATIENT WITH ACUTE/CHRONIC HYPOXIA - INTUBATED FOR VENTILATORY SUPPORT - CARDIOPULMONARY ARREST/CPR, REQUIRED SUCTIONING. SUCTION PUMP FAILURE AS A RESULT OF STAFF MODIFICATION OF EQUIPMENT (PLACEMENT OF TAPE INTENDED TO STABLIZE SUCTION CANISTER ON STAND OPENED SAFETY VALVE WHICH THEN DISABLED APPARATUS). ALTERNATIVE SOURCE OF SUCTION WAS AVAILABLE AND USED EFFECTIVELY, BUT PATIENT LATER EXPIRED. NOTE: THERE IS NO EVIDENCE THAT DELAY IN SUCTIONING CAUSED OR CONTRIBUTED TO PATIENT'S DEATH BUT THIS REPORT HAS BEEN SUBMITTED BECAUSE THE EVENT (DEVICE FAILURE) OCCURRED WITH TWO CONSECUTIVE DEVICE INTERVENTIONS.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-OCT-91. SERVICE PROVIDED BY: USER FACILITY BIOMEDICAL/BIOENGINEERING DEPARTMENT. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, ELECTRICAL TESTS PERFORMED, MECHANICAL TESTS PERFORMED, PERFORMANCE TESTS PERFORMED. RESULTS OF EVALUATION: MODIFICATION OF DEVICE - BY USER, OTHER, PATIENT'S CONDITION - PREDISPOSED EVENT. CONCLUSION: DEVICE FAILURE OCCURRED BUT NOT RELATED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE, USER EDUCATION PROVIDED, INSERVICED BY OTHER FACILITY STAFF. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.